GAMBRO DIGITAL TELETHERMOMETER TTH 10-200— 510(k) K852455

Name: FDA 510(k) clearance K852455
Creator: U.S. Food and Drug Administration
Published: 1985-09-16

Substantially Equivalent

Gambro, Inc.

FDA 510(k) clearance K852455 for GAMBRO DIGITAL TELETHERMOMETER TTH 10-200, Substantially Equivalent on 1985-09-16. Applicant: Gambro, Inc.. Device class: 1.

Clearance details

Applicant: Gambro, Inc.
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 1985-06-10
Decision date: 1985-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lincolnshire, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.