The following data is part of a premarket notification filed by Mckesson Israel Ltd. with the FDA for Mckesson Cardiology Ecg Mobile.
| Device ID | K133534 |
| 510k Number | K133534 |
| Device Name: | MCKESSON CARDIOLOGY ECG MOBILE |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MCKESSON ISRAEL LTD. 5995 WINDWARD PARKWAY Alpharetta, GA 30005 |
| Contact | Paul Sumner |
| Correspondent | Paul Sumner MCKESSON ISRAEL LTD. 5995 WINDWARD PARKWAY Alpharetta, GA 30005 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-18 |
| Decision Date | 2014-04-18 |
| Summary: | summary |