K782142 is an FDA 510(k) clearance for the ILLIMINATOR, MODEL 265 NASAL. This device is classified as a Otoscope (Class I - General Controls, product code ERA).
Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1979, 30 days after receiving the submission on December 27, 1978.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.
| 510(k) Number | K782142 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 1978 |
| Decision Date | January 26, 1979 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | ERA — Otoscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4770 |