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510(k) K963210

VAIL 100 PEDIATRIC CRIB by Vail Products, Inc. — Product Code FMS

K963210 is an FDA 510(k) premarket notification submitted by Vail Products, Inc. for the device "VAIL 100 PEDIATRIC CRIB". The FDA issued a decision of Substantially Equivalent on November 13, 1996. The device falls under product code FMS (Bed, Pediatric Open Hospital), a Class II device regulated under 21 CFR 880.5140. Vail Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1996
Date Received
August 16, 1996
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 Vail Products, Inc.

  • K982783 — VAIL 1000 ENCLOSED BED (October 5, 1998)
  • K963622 — VAIL 2000 ENCLOSED BED (May 7, 1997)
  • K963589 — VAIL 3000 BED ENCLOSURE (April 21, 1997)

Other clearances for product code FMS

  • K970334 — NATURE'S CRADLE (April 25, 1997)
  • 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