ClearanceBrief
510(k) K040596 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic

ULTRASOUND IMAGING SYSTEM, MODEL 7300

ApplicantEsaote, S.p.A., Indianpolis IN, US
DecisionSubstantially Equivalent, Mar 31, 2004
ReceivedMar 8, 2004
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K040596

DateFirm and productCodeLinked 510(k)
Aug 8, 2014Biosound Esaote, Inc.
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Terminated		 JOPNone listed
Aug 25, 2005Biosound Esaote, Inc.
MyLab30CV Ultrasound Imaging System; model 9807300000.
Terminated		 IYNNone listed
Aug 25, 2005Biosound Esaote, Inc.
MyLab30CV Ultrasound Imaging System; model 9807300001.
Terminated		 IYNNone listed
Aug 25, 2005Biosound Esaote, Inc.
MyLab25 Ultrasound Imaging System; Model 9807300002.
Terminated		 IYNNone listed

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