CipherOx CRI M1
FDA 510(k) K173929 · Flashback Technologies, Inc.
510(k) numberK173929
Submission
- Device name
- CipherOx CRI M1
- Applicant
- Flashback Technologies, Inc.
Louisville, CO, US - Received
- December 26, 2017
- Decision date
- July 24, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PPW – Adjunctive Cardiovascular Status Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2200
- Specialty
- 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.
Other 510(k)s with product code PPW
| 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 |
More from Flashback Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213255 | CipherOx CRI TabletPPW · Traditional | 06/17/2022SE |
Questions and answers
When was CipherOx CRI M1 cleared by the FDA?
CipherOx CRI M1 (K173929) received a 510(k) decision of Substantially Equivalent on July 24, 2018, 210 days after the submission was received.
What is the product code of K173929?
The FDA product code is PPW – Adjunctive Cardiovascular Status Indicator, a Class II (moderate risk) device regulated under 21 CFR 870.2200.