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510(k) K890012

HUNTLEIGH DYNAMIC FLOTATION SYSTEM by Huntleigh Technology, Inc. — Product Code FNM

K890012 is an FDA 510(k) premarket notification submitted by Huntleigh Technology, Inc. for the device "HUNTLEIGH DYNAMIC FLOTATION SYSTEM". The FDA issued a decision of Substantially Equivalent on March 29, 1989. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Huntleigh Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1989
Date Received
January 3, 1989
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 Huntleigh Technology, Inc.

  • K992733 — AKRON ATP9 TRACTION MACHINE (November 10, 1999)
  • K964699 — RHEO DOPPLEX II (RD 2) (February 21, 1997)
  • K924516 — OP3/VP4 (June 28, 1993)
  • K910188 — FLOWPLUS AC330 PUMP GARMENTS (May 28, 1991)
  • K900882 — MULTI DOPPLEX, MD-1 (August 22, 1990)
  • K900618 — HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140 (April 25, 1990)
  • K884451 — DOPCORD PPG (January 12, 1989)
  • K881632 — FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT (September 26, 1988)
  • K874688 — FLOWTRON AC200/2 (September 23, 1988)
  • K882644 — HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 (August 10, 1988)

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