K003222 is an FDA 510(k) clearance for the MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER. This device is classified as a Laryngoscope, Endoscope (Class II - Special Controls, product code GCI).
Submitted by Computer Motion, Inc. (Goleta, US). The FDA issued a Cleared decision on November 3, 2000, 18 days after receiving the submission on October 16, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K003222 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 16, 2000 |
| Decision Date | November 03, 2000 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GCI — Laryngoscope, Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |