SIMPEX INC. ORAL AND RECTAL THERMOMETERS— 510(k) K913793

Name: FDA 510(k) clearance K913793
Creator: U.S. Food and Drug Administration
Published: 1991-12-30

Substantially Equivalent

Simpex, Inc.

FDA 510(k) clearance K913793 for SIMPEX INC. ORAL AND RECTAL THERMOMETERS, Substantially Equivalent on 1991-12-30. Applicant: Simpex, Inc.. Device class: 2.

Clearance details

Applicant: Simpex, Inc.
Product code: Code FLK
Device class: Class 2
Regulation: 21 CFR 880.2920
Advisory panel: General Hospital
Date received: 1991-08-23
Decision date: 1991-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jenkintown, PA, US

Download summary PDF View on FDA.gov ↗

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