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510(k) K953675

ALTADYNE by Lumex, Inc. — Product Code FNM

K953675 is an FDA 510(k) premarket notification submitted by Lumex, Inc. for the device "ALTADYNE". The FDA issued a decision of Substantially Equivalent on September 28, 1995. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Lumex, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1995
Date Received
August 7, 1995
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 Lumex, Inc.

  • K963674 — LUMEX AIR (January 10, 1997)
  • K962123 — AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM (July 18, 1996)
  • K945175 — MECHANICAL WHEELCHAIR 890.3850 (May 12, 1995)
  • K945257 — 577ES (ERGOSENSE) (April 26, 1995)
  • K944574 — LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI) (October 17, 1994)
  • K923977 — AKROTECH 4000 (February 12, 1993)
  • K895740 — SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART (February 22, 1990)

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