EMG MODULE, EMG1, W/OPTIONAL SPEAKER— 510(k) K842124

Substantially Equivalent

Endotek Corp.

FDA 510(k) clearance K842124 for EMG MODULE, EMG1, W/OPTIONAL SPEAKER, Substantially Equivalent on 1984-08-08. Applicant: Endotek Corp.. Device class: 2.

Clearance details

Applicant
Endotek Corp.
Product code
Code FAP
Device class
Class 2
Regulation
21 CFR 876.1620
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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