MODEL 1700, HYDRO PREP— 510(k) K970694

Clearance details

Applicant

Physiometrix, Inc.

Product code

Code GYB

Device class

Class 2

Regulation

21 CFR 882.1275

Advisory panel

Neurology

Date received

1997-02-25

Decision date

1997-05-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

North Billerica, MA, US

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• Z-0675-2020 — 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 Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep¿ cups are a component in the Subject Kit.Class II·Terminated·Neuronetrix Solutions, LLC dba Cognision·20191107
• Z-0704-2020 — 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 reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.Class II·Terminated·Bio-Signal Group Corp.·20191029
• Z-0705-2020 — 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 between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.Class II·Terminated·Bio-Signal Group Corp.·20191029

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970694.