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510(k) K872924

PARAGON 8500 CARDIO-PULMONARY BED by Surgi-Med, Inc. — Product Code FNL

K872924 is an FDA 510(k) premarket notification submitted by Surgi-Med, Inc. for the device "PARAGON 8500 CARDIO-PULMONARY BED". The FDA issued a decision of Substantially Equivalent on October 9, 1987. The device falls under product code FNL (Bed, Ac-Powered Adjustable Hospital), a Class II device regulated under 21 CFR 880.5100. Surgi-Med, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1987
Date Received
July 27, 1987
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 Surgi-Med, Inc.

  • K881705 — MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM (July 13, 1988)
  • K873047 — KEANE MOBILITY BED (October 15, 1987)
  • K872923 — PARAGON 9000 TILT AND TURN BED (October 14, 1987)
  • K872925 — MEGABED 1000 (September 15, 1987)

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