The following data is part of a premarket notification filed by Mckesson Israel Ltd. with the FDA for Mckesson Cardiology.
Device ID | K151850 |
510k Number | K151850 |
Device Name: | McKesson Cardiology |
Classification | System, Image Processing, Radiological |
Applicant | MCKESSON ISRAEL LTD. HAROKMIM 26 Holon, IL 5885849 |
Contact | Gilbert Wong |
Correspondent | Paul Sumner MCKESSON TECHNOLOGIES, INC. 5995 WINDWARD PARKWAY Alpharetta, GA 30005 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-07 |
Decision Date | 2015-08-11 |
Summary: | summary |