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510(k) K845002

CUDDLE HEART -AUDITORY/VIBRATION DEVICE by International Purchasing Services — Product Code FMS

K845002 is an FDA 510(k) premarket notification submitted by International Purchasing Services for the device "CUDDLE HEART -AUDITORY/VIBRATION DEVICE". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. International Purchasing Services has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
December 26, 1984
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 International Purchasing Services

  • K845003 — CUDDLE CARRIER - INFANT BED (April 23, 1986)
  • K845004 — CRIB CUDDLE - INFANT BED (April 23, 1986)

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