Panels › Cardiovascular › Product code PPW · Class 2
Adjunctive Cardiovascular Status Indicator
Regulation 870.2200
2510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PPW
| Company | 510(k)s | Recalls |
|---|---|---|
| Etiometry, Inc. | 4 | 0 |
| Flashback Technologies, Inc. | 3 | 0 |
| Prolaio, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 3, 2026 | K254066 | Etiometry Platform Etiometry, Inc. | PPW |
| Dec 16, 2025 | K252204 | prolaio eVO2peak Module (Version 1.0) Prolaio, Inc. | PPW |
| Feb 12, 2025 | K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) Etiometry, Inc. | PPW |
| Jul 7, 2023 | K223578 | T3 Platform software Etiometry, Inc. | PPW |
| Jun 22, 2022 | K213230 | T3 Platform Software Etiometry, Inc. | PPW |
| Jun 17, 2022 | K213255 | CipherOx CRI Tablet Flashback Technologies, Inc. | PPW |
| Jul 24, 2018 | K173929 | CipherOx CRI M1 Flashback Technologies, Inc. | PPW |
| Dec 21, 2016 | DEN160020 | CipherOx CRI Tablet Flashback Technologies, Inc. | PPW |
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