510(k) K982255

MODEL 2000 PULSE OXIMETER by Ivy Biomedical Systems, Inc. — Product Code DQA

K982255 is an FDA 510(k) premarket notification submitted by Ivy Biomedical Systems, Inc. for the device "MODEL 2000 PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on October 22, 1998. 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.