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510(k) K883256

BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM by Bio Clinic Co. — Product Code FNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1988
Date Received
August 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Air Flotation, Alternating Pressure
Device Class
Class II
Regulation Number
880.5550
Review Panel
HO
Submission Type

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Other clearances for product code FNM

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  • K955243 — BARIAIR (October 23, 1997)
  • K970468 — KT AIR BED (September 5, 1997)
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  • K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS (July 31, 1997)