PPW — Adjunctive Cardiovascular Status Indicator Class II
Classification Details
- Product Code
- PPW
- Device Class
- Class II
- Regulation Number
- 870.2200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252204 | prolaio | prolaio eVO2peak Module (Version 1.0) | December 16, 2025 |
| K241479 | etiometry | Etiometry Platform (DAV 5.4 RAE 9.2) | February 12, 2025 |
| K223578 | etiometry | T3 Platform software | July 7, 2023 |
| K213230 | etiometry | T3 Platform Software | June 22, 2022 |
| K213255 | flashback technologies | CipherOx CRI Tablet | June 17, 2022 |
| K173929 | flashback technologies | CipherOx CRI M1 | July 24, 2018 |
| DEN160020 | flashback technologies | CipherOx CRI Tablet | December 21, 2016 |