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510(k) K970334

NATURE'S CRADLE by Infant Advantage, Inc. — Product Code FMS

K970334 is an FDA 510(k) premarket notification submitted by Infant Advantage, Inc. for the device "NATURE'S CRADLE". The FDA issued a decision of Substantially Equivalent on April 25, 1997. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. Infant Advantage, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1997
Date Received
January 28, 1997
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 Infant Advantage, Inc.

  • K960747 — NATURE'S CRADLE MODEL C1500 (May 22, 1996)
  • K951024 — NATURE'S CRADLE (June 5, 1995)
  • K921327 — NATURE'S CRADLE HM-10 (December 29, 1992)
  • K901763 — NATURE'S CRADLE(TM) (March 22, 1991)

Other clearances for product code FMS

  • 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)
  • K950059 — MC INFANT CARE UNIE #PP30 (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