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510(k) K951514

SSC MODEL 4000 SERIES by Ssc Medical Products, Inc. — Product Code FNL

K951514 is an FDA 510(k) premarket notification submitted by Ssc Medical Products, Inc. for the device "SSC MODEL 4000 SERIES". The FDA issued a decision of Substantially Equivalent on March 6, 1996. 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
March 6, 1996
Date Received
April 3, 1995
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

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  • 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