510(k) K901504

MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP. by Ivy Biomedical Systems, Inc. — Product Code DQA

K901504 is an FDA 510(k) premarket notification submitted by Ivy Biomedical Systems, Inc. for the device "MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.". The FDA issued a decision of Substantially Equivalent on August 23, 1990. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Ivy Biomedical Systems, Inc. has at least 10 other 510(k) clearances on record.