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510(k) K950059

MC INFANT CARE UNIE #PP30 by Janco Consulting Services — Product Code FMS

K950059 is an FDA 510(k) premarket notification submitted by Janco Consulting Services for the device "MC INFANT CARE UNIE #PP30". The FDA issued a decision of Substantially Equivalent on February 10, 1995. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. Janco Consulting Services has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1995
Date Received
January 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Pediatric Open Hospital
Device Class
Class II
Regulation Number
880.5140
Review Panel
HO
Submission Type

Other clearances by Janco Consulting Services

  • K951161 — MC ACCLAIM Q6000 BED (May 9, 1995)
  • K950058 — MC HEALTHCARE #CH31 CHILD'S CRIB (February 10, 1995)

Other clearances for product code FMS

  • K970334 — NATURE'S CRADLE (April 25, 1997)
  • K963210 — VAIL 100 PEDIATRIC CRIB (November 13, 1996)
  • K960747 — NATURE'S CRADLE MODEL C1500 (May 22, 1996)
  • K960012 — STRYKER ADEL BASSINET (March 25, 1996)
  • K951024 — NATURE'S CRADLE (June 5, 1995)
  • K950058 — MC HEALTHCARE #CH31 CHILD'S CRIB (February 10, 1995)
  • K950051 — BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B (February 10, 1995)
  • K925530 — INSTRUMENT WARMER (June 18, 1993)
  • K925949 — PEDICRAGT BASSINET (April 20, 1993)
  • K925817 — HEAD & FOOT END DROP PEDI-CRIB (April 20, 1993)

FDA data resources