The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll Propaq Xm.
| Device ID | K121367 |
| 510k Number | K121367 |
| Device Name: | ZOLL PROPAQ XM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Contact | Charles W Kolifrath |
| Correspondent | Charles W Kolifrath ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford, MA 01824 -4105 |
| Product Code | MHX |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-07 |
| Decision Date | 2012-06-21 |
| Summary: | summary |