Fluke Inc

⚠️ Moderate Risk

FEI: 3003805791 • Reno, NV • UNITED STATES

FEI

FEI Number

3003805791

📍

Location

Reno, NV

🇺🇸

Country

UNITED STATES

🏢

Address

2000 Arrow Head Carson Ci Nv, , Reno, NV, United States

Moderate Risk

FDA Import Risk Assessment

44.1

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

11/21/2002

Latest Refusal

11/21/2002

Earliest Refusal

Score Breakdown

Violation Severity

60.0×40%

Refusal Volume

37.0×30%

Recency

0.0×20%

Frequency

90.0×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

1189×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

5089×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
11/21/2002	74DTCANALYZER, PACEMAKER GENERATOR FUNCTION	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)
11/21/2002	74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)
11/21/2002	80FRNPUMP, INFUSION	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)
11/21/2002	80FRNPUMP, INFUSION	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)
11/21/2002	74DRSTRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)
11/21/2002	74DRSTRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)
11/21/2002	74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)
11/21/2002	80FRNPUMP, INFUSION	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)
11/21/2002	74DRLTESTER, DEFIBRILLATOR	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Fluke Inc's FDA import refusal history?

Fluke Inc (FEI: 3003805791) has 9 FDA import refusal record(s) in our database, spanning from 11/21/2002 to 11/21/2002.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Fluke Inc's FEI number is 3003805791.

What types of violations has Fluke Inc received?

Fluke Inc has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Fluke Inc come from?

All FDA import refusal data for Fluke Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.