OMNI THERM TEMPERATURE MONITOR— 510(k) K864853

Name: FDA 510(k) clearance K864853
Creator: U.S. Food and Drug Administration
Published: 1987-02-04

Substantially Equivalent

Omni Therm, Inc.

FDA 510(k) clearance K864853 for OMNI THERM TEMPERATURE MONITOR, Substantially Equivalent on 1987-02-04. Applicant: Omni Therm, Inc.. Device class: 2.

Clearance details

Applicant: Omni Therm, Inc.
Product code: Code KPD
Device class: Class 2
Regulation: 21 CFR 880.2200
Advisory panel: General Hospital
Date received: 1986-12-11
Decision date: 1987-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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