510(k) K090438

REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR by Envitec-Wismar GmbH — Product Code DQA

K090438 is an FDA 510(k) premarket notification submitted by Envitec-Wismar GmbH for the device "REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR". The FDA issued a decision of Substantially Equivalent on July 24, 2009. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Envitec-Wismar GmbH has at least 8 other 510(k) clearances on record.