Philips VSC-MEDlib
FDA 510(k) K242001 · Philips Medical Systems Nederland B.V.
510(k) numberK242001
Submission
- Device name
- Philips VSC-MEDlib
- Applicant
- Philips Medical Systems Nederland B.V.
Eindhoven, NL - Received
- July 9, 2024
- Decision date
- April 4, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)BZQ · Traditional | Linshom Medical, Inc. | 09/11/2024SE |
| K223681 | Respiree Cardio-Respiratory MonitorBZQ · Traditional | Respiree Pte, Ltd. | 03/08/2023SE |
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Questions and answers
When was Philips VSC-MEDlib cleared by the FDA?
Philips VSC-MEDlib (K242001) received a 510(k) decision of Substantially Equivalent on April 4, 2025, 269 days after the submission was received.
What is the product code of K242001?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.