K932771 is an FDA 510(k) clearance for the BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE. This device is classified as a Source, Carrier, Fiberoptic Light (Class I - General Controls, product code EQH).
Submitted by Xomed-Treace, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 24, 1994, 442 days after receiving the submission on June 8, 1993.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4350.
| 510(k) Number | K932771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1993 |
| Decision Date | August 24, 1994 |
| Days to Decision | 442 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | EQH — Source, Carrier, Fiberoptic Light |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4350 |