THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2— 510(k) K872529

Name: FDA 510(k) clearance K872529
Creator: U.S. Food and Drug Administration
Published: 1987-09-15

Substantially Equivalent

American Edwards Laboratories

FDA 510(k) clearance K872529 for THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2, Substantially Equivalent on 1987-09-15. Applicant: American Edwards Laboratories. Device class: 2.

Clearance details

Applicant: American Edwards Laboratories
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1987-06-26
Decision date: 1987-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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