PHILIPS MEDICAL SYSTEMS AED
✅ Low Risk
FEI: 3015156458 • Bothell, WA • UNITED STATES
FEI Number
3015156458
Location
Bothell, WA
Country
UNITED STATESAddress
22100 Bothell Everett Hwy, , Bothell, WA, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is PHILIPS MEDICAL SYSTEMS AED's FDA import refusal history?
PHILIPS MEDICAL SYSTEMS AED (FEI: 3015156458) has 2 FDA import refusal record(s) in our database, spanning from 11/22/2019 to 11/17/2021.
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. PHILIPS MEDICAL SYSTEMS AED's FEI number is 3015156458.
What types of violations has PHILIPS MEDICAL SYSTEMS AED received?
PHILIPS MEDICAL SYSTEMS AED has been cited for 1 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 PHILIPS MEDICAL SYSTEMS AED come from?
All FDA import refusal data for PHILIPS MEDICAL SYSTEMS AED 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.