Submission Details
| 510(k) Number | K062230 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 2006 |
| Decision Date | August 31, 2006 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
K062230 is an FDA 510(k) clearance for the MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002, a Laryngoscope, Rigid (Class I — General Controls, product code CCW), submitted by Minrad, Inc. (Buffalo, US). The FDA issued a Cleared decision on August 31, 2006, 29 days after receiving the submission on August 2, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5540.
| 510(k) Number | K062230 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 2006 |
| Decision Date | August 31, 2006 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCW — Laryngoscope, Rigid |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5540 |