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510(k) K935949

STRYKER 5000 by Stryker Medical — Product Code FNM

K935949 is an FDA 510(k) premarket notification submitted by Stryker Medical for the device "STRYKER 5000". The FDA issued a decision of Substantially Equivalent on June 17, 1994. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Stryker Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1994
Date Received
December 13, 1993
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 Stryker Medical

  • K222818 — Xpedition ™ Powered Stair Chair (625700000000) (January 24, 2023)
  • K180834 — Altrix Precision Temperature Management System (August 10, 2018)
  • K171149 — Altrix Temperature Management Wraps (July 18, 2017)
  • K152266 — Altrix Precision Temperature Management System (December 2, 2016)
  • K113598 — POWER-LOAD COT FASTENER SYSTEM (December 20, 2011)
  • K946149 — STRYKER AGILITY INTENSIVE CARE BED (March 14, 1995)
  • K943864 — STRYKER 8000 SURGERY STRETCHER (August 25, 1994)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K940068 — STRYKER OPERATING ROOM TABLE (May 5, 1994)
  • K935297 — STRYKER AMBULANCE COT MODEL 6060 (February 18, 1994)

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