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510(k) K861678

COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED by Sierra Corp. — Product Code FNJ

K861678 is an FDA 510(k) premarket notification submitted by Sierra Corp. for the device "COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED". The FDA issued a decision of Substantially Equivalent on May 8, 1986. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1986
Date Received
May 1, 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 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