LOW AIR LOSS MATTRESS, MODIFICATION— 510(k) K934689

Name: FDA 510(k) clearance K934689
Creator: U.S. Food and Drug Administration
Published: 1994-02-02

Substantially Equivalent

Cardio Systems, Inc.

FDA 510(k) clearance K934689 for LOW AIR LOSS MATTRESS, MODIFICATION, Substantially Equivalent on 1994-02-02. Applicant: Cardio Systems, Inc.. Device class: 2.

Clearance details

Applicant: Cardio Systems, Inc.
Product code: Code INX
Device class: Class 2
Regulation: 21 CFR 890.5160
Advisory panel: Physical Medicine
Date received: 1993-08-23
Decision date: 1994-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

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