The following data is part of a premarket notification filed by Diagnostic Monitoring Software with the FDA for Dms 300-2w Holter Ecg Recorder.
| Device ID | K133014 |
| 510k Number | K133014 |
| Device Name: | DMS 300-2W HOLTER ECG RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | DIAGNOSTIC MONITORING SOFTWARE 290 Kingsbury Grade # 3 Stateline, NV 89449 |
| Contact | William Parsons |
| Correspondent | William Parsons DIAGNOSTIC MONITORING SOFTWARE 290 Kingsbury Grade # 3 Stateline, NV 89449 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-25 |
| Decision Date | 2014-05-19 |
| Summary: | summary |