The following data is part of a premarket notification filed by Exelys Llc with the FDA for Mh1 Microholter Recorder.
| Device ID | K101969 |
| 510k Number | K101969 |
| Device Name: | MH1 MICROHOLTER RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | EXELYS LLC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Neal Kolber |
| Correspondent | Neal Kolber EXELYS LLC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-13 |
| Decision Date | 2011-02-04 |
| Summary: | summary |