The following data is part of a premarket notification filed by The Electrode Store, Inc. with the FDA for The Electrode Store Surface (cutaneous) Electrode For Emg.
Device ID | K020445 |
510k Number | K020445 |
Device Name: | THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG |
Classification | Electrode, Cutaneous |
Applicant | THE ELECTRODE STORE, INC. 936-11TH AVENUE EAST Seattle, WA 98102 |
Contact | Carl Youngmann |
Correspondent | Carl Youngmann THE ELECTRODE STORE, INC. 936-11TH AVENUE EAST Seattle, WA 98102 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-11 |
Decision Date | 2002-05-10 |