ClearanceBrief
510(k) K041266 ยท KGI Densitometer, Bone

PEDIATRIC REFERENCE DATABASE

ApplicantHologic, Inc., Bedford MA, US
DecisionSubstantially Equivalent, Aug 11, 2004
ReceivedMay 12, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K041266

DateFirm and productCodeLinked 510(k)
Nov 11, 2004Draeger Medical, Inc.
APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines.
Terminated
BSZNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.