510(k) K241479
- Device
- Etiometry Platform (DAV 5.4 RAE 9.2)
- Applicant
- Etiometry, Inc.
- 510(k) number
- K241479
- Product code
- PPW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-12
- Date received
- 2024-05-24
- Regulation
- 870.2200
- Classification name
- Adjunctive Cardiovascular Status Indicator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Tim Hanson
- Address
- 280 Summer St. Fourth Floor Boston MA US 02210 02210
FDA Registration Numbers#
- 3008061490
- 3030597723
- 3011683100
Source Documents#
Other 510(k) Records For Product Code PPW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254066 | Etiometry Platform | Etiometry, Inc. | 2026-04-03 |
| K252204 | prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. | 2025-12-16 |
| K223578 | T3 Platform software | Etiometry, Inc. | 2023-07-07 |
| K213230 | T3 Platform Software | Etiometry, Inc. | 2022-06-22 |
| K213255 | CipherOx CRI Tablet | Flashback Technologies, Inc. | 2022-06-17 |
| K173929 | CipherOx CRI M1 | Flashback Technologies, Inc. | 2018-07-24 |
| DEN160020 | CipherOx CRI Tablet | Flashback Technologies, Inc. | 2016-12-21 |