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510(k) K934689

LOW AIR LOSS MATTRESS, MODIFICATION by Cardio Systems, Inc. — Product Code INX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1994
Date Received
August 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Air Fluidized
Device Class
Class II
Regulation Number
890.5160
Review Panel
PM
Submission Type

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