Respiree Cardio- Respiratory Monitor System— 510(k) K250934

Name: FDA 510(k) clearance K250934
Creator: U.S. Food and Drug Administration
Published: 2025-08-05

Substantially Equivalent

Respiree Pte, Ltd.

FDA 510(k) clearance K250934 for Respiree Cardio- Respiratory Monitor System, Substantially Equivalent on 2025-08-05. Applicant: Respiree Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Respiree Pte, Ltd.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2025-03-28
Decision date: 2025-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore Central, SG

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZQ

view all

K253274 — BedDot (G1)2026-06-25
K251326 — Respiration Rate algorithm2026-06-11
K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)2025-09-26
K243183 — RTMsense Respiratory Monitoring System2025-06-27
K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)2025-04-09

More clearances from Respiree Pte, Ltd.

view all

K223681 — Respiree Cardio-Respiratory Monitor2023-03-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.