K003661 is an FDA 510(k) clearance for the SOCRATES ROBOTIC TELEMONITORING SYSTEM. This device is classified as a Device, Telemedicine, Robotic (Class II - Special Controls, product code NEQ).
Submitted by Computer Motion, Inc. (Goleta, US). The FDA issued a Cleared decision on October 5, 2001, 311 days after receiving the submission on November 28, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K003661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2000 |
| Decision Date | October 05, 2001 |
| Days to Decision | 311 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEQ — Device, Telemedicine, Robotic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |