DXP1000 Holter Recorder
by Braemar Corp. 510(k)
Active
510(k) K993618
Overview
The DXP1000 Holter Recorder is an ambulatory electrocardiograph device without analysis. It provides high-quality ECG digital recordings with no data compression.
The device is supplied by Braemar Corp. and is classified as Class II with special controls. It features high-speed USB data transfer and was FDA cleared on November 24, 1999 under K993618.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993618 | Date24 Nov 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MWJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Braemar Corp.
Questions
What is the DXP1000 Holter Recorder used for?
The DXP1000 Holter Recorder is an ambulatory electrocardiograph device without analysis that provides high-quality ECG digital recordings with no data compression for monitoring heart activity outside of clinical settings.
How is the DXP1000 Holter Recorder supplied?
The DXP1000 Holter Recorder is supplied by Braemar Corp. and features high-speed USB data transfer for efficient data retrieval and analysis.
What is the regulatory classification of the DXP1000 Holter Recorder?
The DXP1000 Holter Recorder is classified as Class II with special controls and was FDA cleared on November 24, 1999 under K993618, making it substantially equivalent to other devices in its class.
Is the DXP1000 Holter Recorder reusable or single-use?
The device data does not specify whether the DXP1000 Holter Recorder is designed for single-use or multiple uses, so this information would need to be obtained directly from the manufacturer.