510(k) K911191

PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR by Palco Laboratories, Inc. — Product Code DQA

K911191 is an FDA 510(k) premarket notification submitted by Palco Laboratories, Inc. for the device "PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR". The FDA issued a decision of Substantially Equivalent on June 10, 1991. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Palco Laboratories, Inc. has at least 8 other 510(k) clearances on record.