THERMO-5000— 510(k) K895358

Substantially Equivalent

Medtronix Ltd., Inc.

FDA 510(k) clearance K895358 for THERMO-5000, Substantially Equivalent on 1990-05-07. Applicant: Medtronix Ltd., Inc.. Device class: 1.

Clearance details

Applicant: Medtronix Ltd., Inc.
Product code: Code LHQ
Device class: Class 1
Regulation: 21 CFR 884.2980
Advisory panel: Obstetrics/Gynecology
Date received: 1989-08-28
Decision date: 1990-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Commerce, GA, 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.