510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K943238Substantially Equivalent

Norelco Clean Air System

Philips Electronic North America Corp. (Pena), Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943238 is the FDA 510(k) clearance record for NORELCO CLEAN AIR SYSTEM, a class II device, cleared for Philips Electronic North America Corp. (Pena) on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list one 510(k) clearance for Philips Electronic North America Corp. (Pena). As of , FDA records show no recalls naming K943238.

Clearance record

Decision date
Received
(145 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Philips Electronic North America Corp. (Pena) 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code FRF

Trailing 12 months
1 clearance under product code FRF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260