510(k) K192900

H500 Multi-Sensing Oximetry System by Nonin Medical, Inc. — Product Code DQA

K192900 is an FDA 510(k) premarket notification submitted by Nonin Medical, Inc. for the device "H500 Multi-Sensing Oximetry System". The FDA issued a decision of Substantially Equivalent on June 29, 2020. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Nonin Medical, Inc. has at least 10 other 510(k) clearances on record.