The following data is part of a premarket notification filed by Change Healthcare Israel Ltd. with the FDA for Change Healthcare Cardiology.
| Device ID | K212528 |
| 510k Number | K212528 |
| Device Name: | Change Healthcare Cardiology |
| Classification | System, Image Processing, Radiological |
| Applicant | Change Healthcare Israel Ltd. 26 Harokmim St. Holon, IL 5885849 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy Change Healthcare Canada Company 10711 Cambie Road Richmond, CA V6x3g5 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-11 |
| Decision Date | 2021-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17540262090109 | K212528 | 000 |
| 17540262090116 | K212528 | 000 |
| 17540262090130 | K212528 | 000 |