K971968 is an FDA 510(k) clearance for the SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97). This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 23, 1997, 56 days after receiving the submission on May 28, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K971968 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1997 |
| Decision Date | July 23, 1997 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DSA - Cable, Transducer And Electrode, Patient, (including Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2900 |