The following data is part of a premarket notification filed by Mckesson Israel Ltd. with the FDA for Mckesson Cardiology Hemo.
| Device ID | K131497 |
| 510k Number | K131497 |
| Device Name: | MCKESSON CARDIOLOGY HEMO |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| 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 | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-24 |
| Decision Date | 2013-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80010939050027 | K131497 | 000 |
| 17540262100020 | K131497 | 000 |
| 17540262100013 | K131497 | 000 |
| 17540262100044 | K131497 | 000 |
| 17540262100051 | K131497 | 000 |
| 17540262100099 | K131497 | 000 |
| 17540262100105 | K131497 | 000 |
| 17540262100037 | K131497 | 000 |
| 17540262100129 | K131497 | 000 |