K791013 is an FDA 510(k) clearance for the SPECTRA R PAD. This device is classified as a Media, Electroconductive (Class II - Special Controls, product code GYB).
Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979, 108 days after receiving the submission on June 1, 1979.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1275.
| 510(k) Number | K791013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1979 |
| Decision Date | September 17, 1979 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GYB — Media, Electroconductive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1275 |