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510(k) K963589

VAIL 3000 BED ENCLOSURE by Vail Products, Inc. — Product Code FNL

K963589 is an FDA 510(k) premarket notification submitted by Vail Products, Inc. for the device "VAIL 3000 BED ENCLOSURE". The FDA issued a decision of Substantially Equivalent on April 21, 1997. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Vail Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1997
Date Received
September 9, 1996
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 Vail Products, Inc.

  • K982783 — VAIL 1000 ENCLOSED BED (October 5, 1998)
  • K963622 — VAIL 2000 ENCLOSED BED (May 7, 1997)
  • K963210 — VAIL 100 PEDIATRIC CRIB (November 13, 1996)

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)
  • K962942 — TOTALCARE (February 3, 1997)
  • K963701 — SOMA SAFE ENCLOSURE (January 24, 1997)

FDA data resources