MODEL SP1465 CARDIAC OUTPUT COMPUTER— 510(k) K861092

Name: FDA 510(k) clearance K861092
Creator: U.S. Food and Drug Administration
Published: 1986-08-18

Substantially Equivalent

Gould, Inc.

FDA 510(k) clearance K861092 for MODEL SP1465 CARDIAC OUTPUT COMPUTER, Substantially Equivalent on 1986-08-18. 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: 1986-03-24
Decision date: 1986-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxnard, CA, US

Download summary PDF View on FDA.gov ↗

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