GABRIEL MEDICAL CLS THERMAL RECORDER— 510(k) K901385

Name: FDA 510(k) clearance K901385
Creator: U.S. Food and Drug Administration
Published: 1990-05-09

Substantially Equivalent

Gabriel Medical, Inc.

FDA 510(k) clearance K901385 for GABRIEL MEDICAL CLS THERMAL RECORDER, Substantially Equivalent on 1990-05-09. Applicant: Gabriel Medical, Inc.. Device class: 1.

Clearance details

Applicant: Gabriel Medical, Inc.
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1990-03-26
Decision date: 1990-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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