K935260 is an FDA 510(k) clearance for the PHYSIOMETRIX CABLE ADAPTER MODIFICATION. This device is classified as a Cable, Electrode (Class II - Special Controls, product code IKD).
Submitted by Physiometrix, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 23, 1993, 51 days after receiving the submission on November 2, 1993.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1175.
| 510(k) Number | K935260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1993 |
| Decision Date | December 23, 1993 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IKD — Cable, Electrode |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1175 |