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510(k) K970081

SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM by Cathay Consolidated, Inc. — Product Code FNM

K970081 is an FDA 510(k) premarket notification submitted by Cathay Consolidated, Inc. for the device "SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM". The FDA issued a decision of Substantially Equivalent on November 7, 1997. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Cathay Consolidated, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1997
Date Received
January 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 by Cathay Consolidated, Inc.

  • K850626 — CARNATION OXYGEN (March 12, 1985)

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)
  • K955243 — BARIAIR (October 23, 1997)
  • K970468 — KT AIR BED (September 5, 1997)
  • K965207 — RID-DECUBE II (August 21, 1997)
  • K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS (July 31, 1997)
  • K954320 — MODIFIED PEDIKAIR (July 18, 1997)

FDA data resources