Home / 510(k) Clearances / K963510

510(k) K963510

APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM by Mellen Air Mfg., Inc. — Product Code FNM

K963510 is an FDA 510(k) premarket notification submitted by Mellen Air Mfg., Inc. for the device "APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 1996. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Mellen Air Mfg., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1996
Date Received
September 3, 1996
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 Mellen Air Mfg., Inc.

  • K961129 — AREMA II (April 17, 1996)

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