Home / 510(k) Clearances / K250093

510(k) K250093

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) by Linshom Medical, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2025
Date Received
January 14, 2025
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

Other clearances by Linshom Medical, Inc.

  • K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (September 11, 2024)

Other clearances for product code BZQ

  • K250934 — Respiree Cardio- Respiratory Monitor System (August 5, 2025)
  • K243183 — RTMsense Respiratory Monitoring System (June 27, 2025)
  • K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (April 9, 2025)
  • K242001 — Philips VSC-MEDlib (April 4, 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)