The following data is part of a premarket notification filed by Mim Software Inc. with the FDA for Mim-ablation.
Device ID | K220256 |
510k Number | K220256 |
Device Name: | MIM-Ablation |
Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
Applicant | MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 |
Contact | Daniel Darkow |
Correspondent | Daniel Darkow MIM Software Inc. 25800 Science Park Drive - Suite 180 Cleveland, OH 44122 |
Product Code | QTZ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-31 |
Decision Date | 2022-10-07 |