510(k) K242001

Philips VSC-MEDlib by Philips Medical Systems Nederland B.V. — Product Code BZQ

K242001 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Philips VSC-MEDlib". The FDA issued a decision of Substantially Equivalent on April 4, 2025. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Philips Medical Systems Nederland B.V. has at least 10 other 510(k) clearances on record.