K830047 is an FDA 510(k) clearance for the FIBER OPTIC LARYNGOSCOPES W/BATTERY. This device is classified as a Laryngoscope, Rigid (Class I - General Controls, product code CCW).
Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1983, 8 days after receiving the submission on January 10, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5540.
| 510(k) Number | K830047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1983 |
| Decision Date | January 18, 1983 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CCW — Laryngoscope, Rigid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5540 |