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510(k) K240271

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2024
Date Received
January 31, 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

Other clearances by Linshom Medical, Inc.

  • K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (September 26, 2025)

Other clearances for product code BZQ

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  • K242798 — Airmod (February 28, 2025)
  • 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)