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510(k) K972153

ALTERNATING PRESSURE AIR FLOTATION MATTRESS by Decubiti Concepts, Inc. — Product Code FNM

K972153 is an FDA 510(k) premarket notification submitted by Decubiti Concepts, Inc. for the device "ALTERNATING PRESSURE AIR FLOTATION MATTRESS". The FDA issued a decision of Substantially Equivalent on July 31, 1997. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1997
Date Received
June 9, 1997
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

Other clearances for product code FNM

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K974319 — MIGHTY AIR (January 22, 1998)
  • K972022 — ZAK-2000 (January 22, 1998)
  • K974070 — PHYSIO/1000 (January 6, 1998)
  • K972549 — SIMPULSE (November 18, 1997)
  • K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (November 7, 1997)
  • K955243 — BARIAIR (October 23, 1997)
  • K970468 — KT AIR BED (September 5, 1997)
  • K965207 — RID-DECUBE II (August 21, 1997)
  • K954320 — MODIFIED PEDIKAIR (July 18, 1997)

FDA data resources