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510(k) K971546

SOMA 900 TRANSPORT BED by Nova Technologies, Inc. — Product Code FNL

K971546 is an FDA 510(k) premarket notification submitted by Nova Technologies, Inc. for the device "SOMA 900 TRANSPORT BED". The FDA issued a decision of Substantially Equivalent on July 10, 1997. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1997
Date Received
April 28, 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 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)
  • 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