510(k) K043463

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

K043463 is an FDA 510(k) premarket notification submitted by Envitec-Wismar GmbH for the device "ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS". The FDA issued a decision of Substantially Equivalent on February 11, 2005. 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.