The following data is part of a premarket notification filed by Flashback Technologies, Inc. with the FDA for Cipherox Cri Tablet.
| Device ID | K213255 |
| 510k Number | K213255 |
| Device Name: | CipherOx CRI Tablet |
| Classification | Adjunctive Cardiovascular Status Indicator |
| Applicant | Flashback Technologies, Inc. 208 Lenox Ave #307 Westfield, NJ 07090 |
| Contact | John Jedziniak |
| Correspondent | Paul Dryden ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704 |
| Product Code | PPW |
| CFR Regulation Number | 870.2200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2022-06-17 |