510(k) K070193

ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES by Envitec-Wismar GmbH — Product Code DQA

K070193 is an FDA 510(k) premarket notification submitted by Envitec-Wismar GmbH for the device "ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on May 2, 2007. 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.