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 |