The following data is part of a premarket notification filed by Braemar Corp. with the FDA for Dxp1000 Holter Recorder.
| Device ID | K993618 |
| 510k Number | K993618 |
| Device Name: | DXP1000 HOLTER RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | BRAEMAR CORP. 11481 RUPP DR. Burnsville, MN 55337 |
| Contact | David Norberg |
| Correspondent | David Norberg BRAEMAR CORP. 11481 RUPP DR. Burnsville, MN 55337 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-26 |
| Decision Date | 1999-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B146DL8NVE0 | K993618 | 000 |
| B146DL8NV0 | K993618 | 000 |
| B146DL8NO2560 | K993618 | 000 |
| B146DL8FM0 | K993618 | 000 |
| B146DL8CN0 | K993618 | 000 |
| B146DL8CL0 | K993618 | 000 |
| B146DL8BD0 | K993618 | 000 |
| B146DL8B1330 | K993618 | 000 |
| B146DL8256B0 | K993618 | 000 |