MODIFIED GAS-STAT(TM) MONITORING SYSTEM— 510(k) K864703

Name: FDA 510(k) clearance K864703
Creator: U.S. Food and Drug Administration
Published: 1987-02-19

Substantially Equivalent

Cardiovascular Devices, Inc.

FDA 510(k) clearance K864703 for MODIFIED GAS-STAT(TM) MONITORING SYSTEM, Substantially Equivalent on 1987-02-19. Applicant: Cardiovascular Devices, Inc.. Device class: 2.

Clearance details

Applicant: Cardiovascular Devices, Inc.
Product code: Code DTY
Device class: Class 2
Regulation: 21 CFR 870.4410
Advisory panel: Cardiovascular
Date received: 1986-12-02
Decision date: 1987-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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