K922095 is an FDA 510(k) clearance for the LX 150 LIGHT SOURCE. This device is classified as a Source, Carrier, Fiberoptic Light (Class I - General Controls, product code EQH).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 17, 1992, 73 days after receiving the submission on May 5, 1992.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4350.
| 510(k) Number | K922095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 1992 |
| Decision Date | July 17, 1992 |
| Days to Decision | 73 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 |