510(k) K102270

ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN by Envitec-Wismar GmbH — Product Code DQA

K102270 is an FDA 510(k) premarket notification submitted by Envitec-Wismar GmbH for the device "ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN". The FDA issued a decision of Substantially Equivalent on February 22, 2011. 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.