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510(k) K060986

HEAD BED by Steven H. Warnock, M.D. — Product Code FRP

K060986 is an FDA 510(k) premarket notification submitted by Steven H. Warnock, M.D. for the device "HEAD BED". The FDA issued a decision of Substantially Equivalent on July 11, 2006. 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
July 11, 2006
Date Received
April 10, 2006
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)
  • K051300 — ROBIN HOOD VEST (December 8, 2005)
  • K041996 — NIGHTFORM (August 3, 2004)
  • K003511 — KENDALL-LTP TURNER SAVE-A-LINE (January 24, 2001)
  • K943017 — NEONATAL RESTRAINT AND COMFORT SYSTEMS (January 19, 1995)
  • K932636 — THE TUCKER SLING (January 26, 1994)
  • K905629 — PEDICRAFT INFANT REFLUX WEDGE (March 13, 1991)
  • K905630 — INFANT REFLUX SLING (March 13, 1991)

FDA data resources