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510(k) K863748

HOSPITAL BED by Global Medical Prods, Inc. — Product Code FNJ

K863748 is an FDA 510(k) premarket notification submitted by Global Medical Prods, Inc. for the device "HOSPITAL BED". The FDA issued a decision of Substantially Equivalent on October 9, 1986. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120. Global Medical Prods, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1986
Date Received
September 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Manual
Device Class
Class I
Regulation Number
880.5120
Review Panel
HO
Submission Type

Other clearances by Global Medical Prods, Inc.

  • K962329 — GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10 (September 12, 1996)
  • K961324 — GLOBAL MEDICAL PRODUCTS SPINAL,CONICAL TIP (SPROTTLE STYLE), WHITACRE STYLE NEED (July 2, 1996)
  • K952275 — GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB (October 11, 1995)
  • K934256 — GLOBAL MEDICAL CUTTING BIOPSY NEEDLE (March 28, 1994)
  • K871556 — MERIVAARA EMERGENCY PATIENT TROLLEY #436 (April 30, 1987)
  • K862959 — MERIVAARA PATIENT TROLLEY - MODEL #416 (September 25, 1986)
  • K862957 — MERIVAARA GERIATRIC CHAIR MODEL 455 (August 21, 1986)
  • K862931 — MERIVAARA OBSTETRIC CHAIR/BED-MODEL 358 (August 7, 1986)

Other clearances for product code FNJ

  • K934298 — KING KRIB (January 26, 1994)
  • K892877 — CRADLE, HOSPITAL BED CLOTHING (June 15, 1989)
  • K885241 — BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT (February 24, 1989)
  • K884542 — SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED (November 21, 1988)
  • K881725 — ENVIROTENT (BED) (November 8, 1988)
  • K881961 — MSI STANDARD BED MODELS: L1097-64 AND L1085-64 (November 1, 1988)
  • K881964 — MSI 3003 SERIES BED (June 28, 1988)
  • K881962 — MSI 2005 SERIES BED (June 3, 1988)
  • K881043 — FOLDING HOSPITAL COT NSN 6530-00-299-8517 (April 12, 1988)
  • K870166 — PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG (March 13, 1987)

FDA data resources