THERMAFLEX, MODEL SD 55 C.P.M.H.— 510(k) K945803

Name: FDA 510(k) clearance K945803
Creator: U.S. Food and Drug Administration
Published: 1995-05-11

Substantially Equivalent

Burke Neutech, Inc.

FDA 510(k) clearance K945803 for THERMAFLEX, MODEL SD 55 C.P.M.H., Substantially Equivalent on 1995-05-11. Applicant: Burke Neutech, Inc.. Device class: 1.

Clearance details

Applicant: Burke Neutech, Inc.
Product code: Code JFA
Device class: Class 1
Regulation: 21 CFR 890.5410
Advisory panel: Physical Medicine
Date received: 1994-11-28
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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