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510(k) K242001

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
July 9, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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  • K250648 — Philips iCT CT system (June 27, 2025)
  • K251397 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR (June 4, 2025)

Other clearances for product code BZQ

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  • K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (April 9, 2025)
  • K233953 — Makani Science™ Respiration Monitoring System (March 28, 2025)
  • K242798 — Airmod (February 28, 2025)
  • K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (September 11, 2024)
  • K223681 — Respiree Cardio-Respiratory Monitor (March 8, 2023)
  • K221555 — Dozee VS (December 15, 2022)
  • K223246 — Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense (November 18, 2022)