CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM— 510(k) K962788

Name: FDA 510(k) clearance K962788
Creator: U.S. Food and Drug Administration
Published: 1997-04-30

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K962788 for CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM, Substantially Equivalent on 1997-04-30. Applicant: Gaymar Industries, Inc.. Device class: 2.

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code IKZ
Device class: Class 2
Regulation: 21 CFR 890.5225
Advisory panel: Physical Medicine
Date received: 1996-07-17
Decision date: 1997-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

Download summary PDF View on FDA.gov ↗

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