510(k) K191207

Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System by Taiwan Aulisa Medical Devices Technologies, Inc. — Product Code DQA

K191207 is an FDA 510(k) premarket notification submitted by Taiwan Aulisa Medical Devices Technologies, Inc. for the device "Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System". The FDA issued a decision of Substantially Equivalent on June 25, 2019. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Taiwan Aulisa Medical Devices Technologies, Inc. has at least 8 other 510(k) clearances on record.