OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR— 510(k) K881004

Name: FDA 510(k) clearance K881004
Creator: U.S. Food and Drug Administration
Published: 1988-05-12

Substantially Equivalent

Keymed, Inc.

FDA 510(k) clearance K881004 for OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR, Substantially Equivalent on 1988-05-12. Applicant: Keymed, Inc.. Device class: 2.

Clearance details

Applicant: Keymed, Inc.
Product code: Code FCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1988-03-09
Decision date: 1988-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Essex Ss2 5qh England, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.