BZQ — Monitor, Breathing Frequency Class II
FDA Device Classification
Classification Details
- Product Code
- BZQ
- Device Class
- Class II
- Regulation Number
- 868.2375
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250093 | linshom medical | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | September 26, 2025 |
| K250934 | respiree pte | Respiree Cardio- Respiratory Monitor System | August 5, 2025 |
| K243183 | rtm vital signs | RTMsense Respiratory Monitoring System | June 27, 2025 |
| K243966 | faceheart | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | April 9, 2025 |
| K242001 | philips medical systems nederland | Philips VSC-MEDlib | April 4, 2025 |
| K233953 | makani science | Makani Science Respiration Monitoring System | March 28, 2025 |
| K242798 | heroic faith international | Airmod | February 28, 2025 |
| K240271 | linshom medical | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | September 11, 2024 |
| K223681 | respiree pte | Respiree Cardio-Respiratory Monitor | March 8, 2023 |
| K221555 | turtle shell technologies private limited | Dozee VS | December 15, 2022 |
| K223246 | baxter healthcare corproration | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | November 18, 2022 |
| K220111 | pmd solutions | RespiraSense | October 7, 2022 |
| K211387 | sound life sciences | Breathe Easy Mobile Respiratory Monitor (MRM) | November 23, 2021 |
| K202018 | hill-rom | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom H | March 4, 2021 |
| K200445 | circadia technologies | The C100 Contactless Breathing Monitor | June 24, 2020 |
| K190734 | linshom management | Linshom Respiratory Monitoring Device (LRMD) | January 30, 2020 |
| K190775 | shenzhen fiber medical technology co. | The RHEA Vital Sign Vigilance System | December 19, 2019 |
| K173976 | masimo corporation | Masimo Acoustic Respiration Sensors, infant and neonate | September 5, 2018 |
| K180079 | hill-rom | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different | May 7, 2018 |
| K171836 | earlysense | EarlySense Bed Sensing Unit | January 4, 2018 |