510(k) K992215

MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED by Envitec-Wismar GmbH — Product Code DQA

K992215 is an FDA 510(k) premarket notification submitted by Envitec-Wismar GmbH for the device "MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED". The FDA issued a decision of Substantially Equivalent on March 29, 2000. 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.