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510(k) K081264

STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 by Children'S Health First, Inc. — Product Code FMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2009
Date Received
May 5, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Restraint, Protective
Device Class
Class I
Regulation Number
880.6760
Review Panel
HO
Submission Type

Other clearances for product code FMQ

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  • K013239 — COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (November 20, 2001)
  • K010818 — INFANT LIMB HOLDER, MODELS 306080 & 306081 (May 24, 2001)
  • K010644 — CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (May 18, 2001)
  • K991591 — BIOTHANE PATIENT RESTRAINT (July 29, 1999)
  • K982178 — VAGABOND SOFT RESTRAINT SYSTEM (January 26, 1999)
  • K980640 — HEELBO WAIST AND CHEST VEST (May 1, 1998)
  • K972446 — PEDO CUSH PEDO CUDDLE (November 13, 1997)
  • K972046 — FULL BODY RESTRAINT SYSTEM (August 15, 1997)