510(k) K120635

EASYONE PRO RESPIRATORY TESTING DEVICE by Ndd Medizitechnik AG — Product Code BTY

K120635 is an FDA 510(k) premarket notification submitted by Ndd Medizitechnik AG for the device "EASYONE PRO RESPIRATORY TESTING DEVICE". The FDA issued a decision of Substantially Equivalent on September 27, 2012. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Ndd Medizitechnik AG has at least 2 other 510(k) clearances on record.