Cleared Traditional

Philips VSC-MEDlib

K242001 · Philips Medical Systems Nederland B.V. · Anesthesiology
Apr 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K242001 is an FDA 510(k) clearance for the Philips VSC-MEDlib, a Monitor, Breathing Frequency (Class II — Special Controls, product code BZQ), submitted by Philips Medical Systems Nederland B.V. (Eindhoven, NL). The FDA issued a Cleared decision on April 4, 2025, 269 days after receiving the submission on July 9, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2375.

Submission Details

510(k) Number K242001 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2024
Decision Date April 04, 2025
Days to Decision 269 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZQ — Monitor, Breathing Frequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2375

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