510(k) K970694 ยท GYB Media, Electroconductive
MODEL 1700, HYDRO PREP
| Applicant | Physiometrix, Inc., North Billerica MA, US |
| Decision | Substantially Equivalent, May 14, 1997 |
| Received | Feb 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2019 | Bio-Signal Group Corp. HydroDot brand:
Wave Prep 4 oz. tubes-Product 1710-03.
An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to re Terminated |
KOY | None listed |
| Dec 18, 2019 | Bio-Signal Group Corp. HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact b Terminated |
KOY | None listed |
| Nov 7, 2019 | Neuronetrix Solutions, LLC dba Cognision Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes.
Order No. D5000, Part No. PN-1720 - Product Usa Terminated |
KOY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.