ClearanceBrief
510(k) K090438 ยท DQA Oximeter

REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR

ApplicantEnvitec-Wismar GmbH, Egale WI, US
DecisionSubstantially Equivalent, Jul 24, 2009
ReceivedFeb 20, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K090438

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.