Norelco Clean Air System
FDA 510(k) K943238 · Philips Electronic North America Corp. (Pena)
510(k) numberK943238
Submission
- Device name
- Norelco Clean Air System
- Applicant
- Philips Electronic North America Corp. (Pena)
Washington, DC, US - Received
- July 6, 1994
- Decision date
- November 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRF – Cleaner, Air, Medical Recirculating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5045
- Specialty
- General Hospital
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Questions and answers
When was Norelco Clean Air System cleared by the FDA?
Norelco Clean Air System (K943238) received a 510(k) decision of Substantially Equivalent on November 28, 1994, 145 days after the submission was received.
What is the product code of K943238?
The FDA product code is FRF – Cleaner, Air, Medical Recirculating, a Class II (moderate risk) device regulated under 21 CFR 880.5045.