K945161 is an FDA 510(k) clearance for the NORELCO CLEAN AIR SYSTEM CAS950. This device is classified as a Cleaner, Air, Medical Recirculating (Class II - Special Controls, product code FRF).
Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on November 28, 1994, 42 days after receiving the submission on October 17, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5045.
| 510(k) Number | K945161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1994 |
| Decision Date | November 28, 1994 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRF — Cleaner, Air, Medical Recirculating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5045 |