ClearanceBrief
510(k) K053346 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic

MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US
DecisionSubstantially Equivalent, Dec 9, 2005
ReceivedDec 2, 2005
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K053346

No recall in the FDA data names this 510(k).

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