K802331 is an FDA 510(k) clearance for the AO FLEXIBLE LARYNGOSCOPE, #LS-7. This device is classified as a Laryngoscope, Non-rigid (Class I - General Controls, product code CAL).
Submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980, 17 days after receiving the submission on September 23, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5530.
| 510(k) Number | K802331 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 1980 |
| Decision Date | October 10, 1980 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAL — Laryngoscope, Non-rigid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5530 |