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510(k) K250934

Respiree Cardio- Respiratory Monitor System by Respiree Pte, Ltd. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2025
Date Received
March 28, 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 Respiree Pte, Ltd.

  • K223681 — Respiree Cardio-Respiratory Monitor (March 8, 2023)

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