TC-1 CARDIAC OUTPUT COMPUTER— 510(k) K761166

Name: FDA 510(k) clearance K761166
Creator: U.S. Food and Drug Administration
Published: 1976-12-09

Substantially Equivalent

Waters Assoc., Inc.

FDA 510(k) clearance K761166 for TC-1 CARDIAC OUTPUT COMPUTER, Substantially Equivalent on 1976-12-09. Applicant: Waters Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Waters Assoc., Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1976-12-01
Decision date: 1976-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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