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510(k) K943017

NEONATAL RESTRAINT AND COMFORT SYSTEMS by K.Bowmed, Inc. — Product Code FRP

K943017 is an FDA 510(k) premarket notification submitted by K.Bowmed, Inc. for the device "NEONATAL RESTRAINT AND COMFORT SYSTEMS". The FDA issued a decision of Substantially Equivalent on January 19, 1995. The device falls under product code FRP (Holder, Infant Position), a Class I device regulated under 21 CFR 880.5680.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1995
Date Received
June 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Infant Position
Device Class
Class I
Regulation Number
880.5680
Review Panel
HO
Submission Type

Other clearances for product code FRP

  • K082367 — INFANT SLEEP BEANIE (June 12, 2009)
  • K090284 — RES-Q INFANT WEDGE AND SLING (June 5, 2009)
  • K062143 — KOZY COMFORT INFANT POSITIONER (October 24, 2006)
  • K060986 — HEAD BED (July 11, 2006)
  • K051300 — ROBIN HOOD VEST (December 8, 2005)
  • K041996 — NIGHTFORM (August 3, 2004)
  • K003511 — KENDALL-LTP TURNER SAVE-A-LINE (January 24, 2001)
  • K932636 — THE TUCKER SLING (January 26, 1994)
  • K905630 — INFANT REFLUX SLING (March 13, 1991)
  • K905629 — PEDICRAFT INFANT REFLUX WEDGE (March 13, 1991)

FDA data resources