510(k) K060675

ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS by Envitec-Wismar GmbH — Product Code DQA

K060675 is an FDA 510(k) premarket notification submitted by Envitec-Wismar GmbH for the device "ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS". The FDA issued a decision of Substantially Equivalent on July 17, 2006. 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.