FDA Product Code
FDA Product Code PPW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2200
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254066 | Etiometry Platform | Etiometry, Inc. | 2026-04-03 | Special | PDF ↗ |
| K252204 | prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. | 2025-12-16 | Traditional | PDF ↗ |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. | 2025-02-12 | Traditional | PDF ↗ |
| K223578 | T3 Platform software | Etiometry, Inc. | 2023-07-07 | Traditional | PDF ↗ |
| K213230 | T3 Platform Software | Etiometry, Inc. | 2022-06-22 | Traditional | PDF ↗ |
| K213255 | CipherOx CRI Tablet | Flashback Technologies, Inc. | 2022-06-17 | Traditional | PDF ↗ |
| K173929 | CipherOx CRI M1 | Flashback Technologies, Inc. | 2018-07-24 | Traditional | PDF ↗ |
| DEN160020 | CipherOx CRI Tablet | Flashback Technologies, Inc. | 2016-12-21 | Direct | — |
Product code PPW · Class II · Cardiovascular. Data: openFDA.