510(k) K253887

Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401) by Philips Medizin Systeme — Product Code DQA

K253887 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme for the device "Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)". The FDA issued a decision of Substantially Equivalent on May 1, 2026. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700.