The following data is part of a premarket notification filed by Cpsi with the FDA for 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 .
Device ID | BK130003 |
510k Number | BK130003 |
Device Name: | 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 |
Classification | Blood Establishment Computer Software And Accessories |
Applicant | CPSI 6600 Wall Street Mobile, AL 36695 |
Product Code | MMH |
CFR Regulation Number | 864.9165 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Abbrevia |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-02-15 |
Decision Date | 2014-04-30 |