K954438 is an FDA 510(k) clearance for the SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE. This device is classified as a Laryngoscope, Rigid (Class I - General Controls, product code CCW).
Submitted by Rms Div. (Palm Harbor, US). The FDA issued a Cleared decision on December 29, 1995, 95 days after receiving the submission on September 25, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5540.
| 510(k) Number | K954438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1995 |
| Decision Date | December 29, 1995 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CCW — Laryngoscope, Rigid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5540 |