The following data is part of a premarket notification filed by Weaver & Co. with the FDA for Pt-100-30 Somatosensory Stimulating Electrode.
Device ID | K874075 |
510k Number | K874075 |
Device Name: | PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE |
Classification | Electrode, Cutaneous |
Applicant | WEAVER & CO. 565-C NUCLA WAY Aurora, CO 80011 |
Contact | David O Weaver |
Correspondent | David O Weaver WEAVER & CO. 565-C NUCLA WAY Aurora, CO 80011 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-06 |
Decision Date | 1987-10-20 |