TX-2 THERMAL DILUTION CARDIAC OUTPUT— 510(k) K834408

Name: FDA 510(k) clearance K834408
Creator: U.S. Food and Drug Administration
Published: 1984-08-23

Substantially Equivalent

Waters Instruments, Inc.

FDA 510(k) clearance K834408 for TX-2 THERMAL DILUTION CARDIAC OUTPUT, Substantially Equivalent on 1984-08-23. Applicant: Waters Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Waters Instruments, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1983-12-14
Decision date: 1984-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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