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510(k) K851552

MERIVAARA HOSPITAL BED by Daun International, Inc. — Product Code FNJ

K851552 is an FDA 510(k) premarket notification submitted by Daun International, Inc. for the device "MERIVAARA HOSPITAL BED". The FDA issued a decision of Substantially Equivalent on May 8, 1985. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120. Daun International, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1985
Date Received
April 16, 1985
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 Daun International, Inc.

  • K852174 — MERIVAARA OBSTETRIC CHAIR/BED MODEL 358 (September 6, 1985)
  • K851550 — MERIVAARA GERIATRIC CHAIR (July 9, 1985)
  • K851548 — AHLBERGS KOMBI I & KOMBI II MOBILE TRANSFER CHAIRS (July 9, 1985)
  • K851553 — MERIUAARA & ERACARE WHEELCHAIRS (July 9, 1985)
  • K852173 — MERIVAARA CRIB TROLLEY-MODEL 381 (June 17, 1985)
  • K851551 — MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES (May 8, 1985)

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