ROBERTSON OBTURATION MONITOR INSUFFLA— 510(k) K802374

Name: FDA 510(k) clearance K802374
Creator: U.S. Food and Drug Administration
Published: 1980-11-24

Substantially Equivalent

Endotek Corp.

FDA 510(k) clearance K802374 for ROBERTSON OBTURATION MONITOR INSUFFLA, Substantially Equivalent on 1980-11-24. 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: 1980-09-29
Decision date: 1980-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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