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510(k) K803307

MATTRESS, AIR FLOATATION, ALTERN. PRESS. by Intl. Medical Equipment Corp. — Product Code FNM

K803307 is an FDA 510(k) premarket notification submitted by Intl. Medical Equipment Corp. for the device "MATTRESS, AIR FLOATATION, ALTERN. PRESS.". The FDA issued a decision of Substantially Equivalent on January 13, 1981. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Intl. Medical Equipment Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1981
Date Received
December 30, 1980
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 Intl. Medical Equipment Corp.

  • K832745 — OC3 FLYER (September 20, 1983)
  • K832321 — ACCES. HEAD CONTROL-POWERED CHEELCHAIR (August 12, 1983)
  • K832325 — BASE ONLY, POWER WHEELCHAIR (August 12, 1983)
  • K832322 — BASE ONLY, TORONTO CHAIR (August 12, 1983)
  • K813104 — POWER DRIVE WHEELCR (November 20, 1981)

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)
  • K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS (July 31, 1997)

FDA data resources