CARDIACINDEX COMPUTER MODEL SP 1435— 510(k) K802476

Name: FDA 510(k) clearance K802476
Creator: U.S. Food and Drug Administration
Published: 1980-11-19

Substantially Equivalent

Gould, Inc.

FDA 510(k) clearance K802476 for CARDIACINDEX COMPUTER MODEL SP 1435, Substantially Equivalent on 1980-11-19. Applicant: Gould, Inc.. Device class: 2.

Clearance details

Applicant: Gould, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1980-10-09
Decision date: 1980-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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