The following data is part of a premarket notification filed by Flashback Technologies, Inc. with the FDA for Cipherox Cri M1.
| Device ID | K173929 |
| 510k Number | K173929 |
| Device Name: | CipherOx CRI M1 |
| Classification | Adjunctive Cardiovascular Status Indicator |
| Applicant | Flashback Technologies, Inc. 80 Health Park Drive, Suite 20 Louisville, CO 80027 |
| Contact | Gregory Z. Grudic |
| Correspondent | Paul Dryden Flashback Technologies, Inc. 80 Health Park Drive, Suite 20 Louisville, CO 80027 |
| Product Code | PPW |
| CFR Regulation Number | 870.2200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-07-24 |
| Summary: | summary |