The following data is part of a premarket notification filed by Change Healthcare Israel Ltd. with the FDA for Mckesson Cardiology.
Device ID | K181080 |
510k Number | K181080 |
Device Name: | McKesson Cardiology |
Classification | System, Image Processing, Radiological |
Applicant | Change Healthcare Israel Ltd. HaRokmim 26 Holon, IL 5885849 |
Contact | Nadia Marchant |
Correspondent | Paul Sumner Change Healthcare Technologies LLC 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 | 2018-04-24 |
Decision Date | 2018-05-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
17540262090024 | K181080 | 000 |
17540262090017 | K181080 | 000 |
17540262090048 | K181080 | 000 |
17540262090055 | K181080 | 000 |
17540262090031 | K181080 | 000 |