The following data is part of a premarket notification filed by Cardiowise, Inc. with the FDA for Squeez Software.
| Device ID | K201250 |
| 510k Number | K201250 |
| Device Name: | SQuEEZ Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Cardiowise, Inc. 535 W. Research Center Blvd., Suite 135 Fayetteville, AR 72701 |
| Contact | John Coats |
| Correspondent | Pierre Bounaud AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave, Suite B-257 San Diego, CA 92110 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-11 |
| Decision Date | 2020-12-18 |