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510(k) K925949

PEDICRAGT BASSINET by Pedicraft, Inc. — Product Code FMS

K925949 is an FDA 510(k) premarket notification submitted by Pedicraft, Inc. for the device "PEDICRAGT BASSINET". The FDA issued a decision of Substantially Equivalent on April 20, 1993. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. Pedicraft, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1993
Date Received
November 24, 1992
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 Pedicraft, Inc.

  • K925817 — HEAD & FOOT END DROP PEDI-CRIB (April 20, 1993)
  • K905629 — PEDICRAFT INFANT REFLUX WEDGE (March 13, 1991)
  • K905630 — INFANT REFLUX SLING (March 13, 1991)
  • K821773 — PEDICRAFT BED, MODEL B2944 (June 23, 1982)

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)
  • 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)
  • K925817 — HEAD & FOOT END DROP PEDI-CRIB (April 20, 1993)

FDA data resources