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510(k) K974296

MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED by Invacare Corp. — Product Code FNL

K974296 is an FDA 510(k) premarket notification submitted by Invacare Corp. for the device "MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED". The FDA issued a decision of Substantially Equivalent on January 6, 1998. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Invacare Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1998
Date Received
November 17, 1997
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 Invacare Corp.

  • K071928 — THE INVACARE FLYER, MODEL IPC 100 (December 12, 2007)
  • K070321 — TWILIGHT FULL FACE MASK (April 30, 2007)
  • K062402 — EASYSTAND EVOLV (September 21, 2006)
  • K061874 — INVACARE'S TWILIGHT II NASAL MASKS (September 5, 2006)
  • K033819 — INVACARE 3G TARSYS (June 4, 2004)
  • K031176 — INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 (March 25, 2004)
  • K031064 — INVACARE POLARIS EX CPAP, MODEL ISP3000 (March 12, 2004)
  • K030814 — INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3 (March 20, 2003)
  • K022642 — TWLIGHT, MODEL ISP 9600 (February 11, 2003)
  • K023589 — STORM TDX POWER WHEELCHAIR (November 19, 2002)

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)
  • 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)
  • K963701 — SOMA SAFE ENCLOSURE (January 24, 1997)

FDA data resources