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510(k) K881019

BABYROCKER by Cinventa AB — Product Code FMS

K881019 is an FDA 510(k) premarket notification submitted by Cinventa AB for the device "BABYROCKER". The FDA issued a decision of Substantially Equivalent on June 7, 1988. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1988
Date Received
March 10, 1988
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 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)
  • K950059 — MC INFANT CARE UNIE #PP30 (February 10, 1995)
  • K950051 — BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B (February 10, 1995)
  • K950058 — MC HEALTHCARE #CH31 CHILD'S CRIB (February 10, 1995)
  • K925530 — INSTRUMENT WARMER (June 18, 1993)
  • K925817 — HEAD & FOOT END DROP PEDI-CRIB (April 20, 1993)

FDA data resources