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510(k) K946149

STRYKER AGILITY INTENSIVE CARE BED by Stryker Medical — Product Code FNL

K946149 is an FDA 510(k) premarket notification submitted by Stryker Medical for the device "STRYKER AGILITY INTENSIVE CARE BED". The FDA issued a decision of Substantially Equivalent on March 14, 1995. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Stryker Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1995
Date Received
December 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Ac-Powered Adjustable Hospital
Device Class
Class II
Regulation Number
880.5100
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)
  • K943864 — STRYKER 8000 SURGERY STRETCHER (August 25, 1994)
  • K935949 — STRYKER 5000 (June 17, 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 FNL

  • K202964 — iBed Wireless with iBed Mobile (June 18, 2021)
  • K103536 — IBED WIRELESS WITH IBED AWARENESS (December 16, 2010)
  • K982783 — VAIL 1000 ENCLOSED BED (October 5, 1998)
  • K974296 — MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED (January 6, 1998)
  • K974254 — BENEFIT B3--- SERIES (December 16, 1997)
  • K972115 — VOLKER HOSPITAL BED, MODEL K960 (August 29, 1997)
  • K971546 — SOMA 900 TRANSPORT BED (July 10, 1997)
  • K963622 — VAIL 2000 ENCLOSED BED (May 7, 1997)
  • K963589 — VAIL 3000 BED ENCLOSURE (April 21, 1997)
  • K962942 — TOTALCARE (February 3, 1997)

FDA data resources