K242001 is an FDA 510(k) clearance for the Philips VSC-MEDlib. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K242001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | BZQ — Monitor, Breathing Frequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |