The following data is part of a premarket notification filed by Mckesson Israel Ltd. with the FDA for Horizon Cardiology Ecg Management.
| Device ID | K113515 |
| 510k Number | K113515 |
| Device Name: | HORIZON CARDIOLOGY ECG MANAGEMENT |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MCKESSON ISRAEL LTD. HANECHOSHET 4 Tel Aviv, IL 69710 |
| Contact | Tomer Levy |
| Correspondent | Tomer Levy MCKESSON ISRAEL LTD. HANECHOSHET 4 Tel Aviv, IL 69710 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-28 |
| Decision Date | 2012-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80010939040028 | K113515 | 000 |
| 17540262110029 | K113515 | 000 |
| 17540262110012 | K113515 | 000 |
| 17540262110043 | K113515 | 000 |
| 17540262110050 | K113515 | 000 |
| 17540262110098 | K113515 | 000 |
| 17540262110104 | K113515 | 000 |
| 17540262110036 | K113515 | 000 |
| 17540262110128 | K113515 | 000 |