COMPUTER, THERMODILUTION CARDIAC (9520)— 510(k) K760192

Name: FDA 510(k) clearance K760192
Creator: U.S. Food and Drug Administration
Published: 1976-07-19

Substantially Equivalent

Edwards Laboratories

FDA 510(k) clearance K760192 for COMPUTER, THERMODILUTION CARDIAC (9520), Substantially Equivalent on 1976-07-19. Applicant: Edwards Laboratories. Device class: 2.

Clearance details

Applicant: Edwards Laboratories
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1976-07-06
Decision date: 1976-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K792441 — CARPENTIER-EDWARDS FLEX. ANNULOPLASTY1980-03-17
K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER1979-12-07
K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A1979-02-26

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