Home / 510(k) Clearances / K945042

510(k) K945042

ELITE 3 LOW AIR LOSS BED by Pegabus Egerton, Ltd. — Product Code FNL

K945042 is an FDA 510(k) premarket notification submitted by Pegabus Egerton, Ltd. for the device "ELITE 3 LOW AIR LOSS BED". The FDA issued a decision of Substantially Equivalent on March 16, 1995. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Pegabus Egerton, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1995
Date Received
October 14, 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 Pegabus Egerton, Ltd.

  • K945041 — PARAGON PORTABLE (March 16, 1995)

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