Adjunctive Cardiovascular Status Indicator
FDA product code PPW · Class II (moderate risk) · 21 CFR 870.2200 · Cardiovascular
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.
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254066 | Etiometry PlatformPPW · Special | Etiometry, Inc. | 04/03/2026SE |
| K252204 | prolaio eVO2peak Module (Version 1.0)PPW · Traditional | Prolaio, Inc. | 12/16/2025SE |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2)PPW · Traditional | Etiometry, Inc. | 02/12/2025SE |
| K223578 | T3 Platform softwarePPW · Traditional | Etiometry, Inc. | 07/07/2023SE |
| K213230 | T3 Platform SoftwarePPW · Traditional | Etiometry, Inc. | 06/22/2022SE |
| K213255 | CipherOx CRI TabletPPW · Traditional | Flashback Technologies, Inc. | 06/17/2022SE |
| K173929 | CipherOx CRI M1PPW · Traditional | Flashback Technologies, Inc. | 07/24/2018SE |