FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
FDA 510(k) K243966 · Faceheart Corp.
510(k) numberK243966
Submission
- Device name
- FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
- Applicant
- Faceheart Corp.
Grand Cayman, KY - Received
- December 23, 2024
- Decision date
- April 9, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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| K233953 | Makani Science Respiration Monitoring SystemBZQ · Traditional | Makani Science, Inc. | 03/28/2025SE |
| K242798 | AirmodBZQ · Traditional | Heroic Faith International , Ltd. | 02/28/2025SE |
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)BZQ · Traditional | Linshom Medical, Inc. | 09/11/2024SE |
| K223681 | Respiree Cardio-Respiratory MonitorBZQ · Traditional | Respiree Pte, Ltd. | 03/08/2023SE |
More from Respiree Pte, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK)QME · Traditional | 09/01/2023SE |
Questions and answers
When was FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) cleared by the FDA?
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (K243966) received a 510(k) decision of Substantially Equivalent on April 9, 2025, 107 days after the submission was received.
What is the product code of K243966?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.