DL900 Series Holter Recorder
FDA 510(k) K071733 · Braemar, Inc.
510(k) numberK071733
Submission
- Device name
- DL900 Series Holter Recorder
- Applicant
- Braemar, Inc.
Eagan, MN, US - Received
- June 26, 2007
- Decision date
- July 24, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MWJ – Electrocardiograph, Ambulatory (Without Analysis)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K081444 | Braemar Fusion Wireless - Ambulatory ECG Arrhythmia Monitoring SystemDSI · Traditional | 07/31/2008SE |
| K072008 | Braemar ER900 Wireless Series Arrhythmia Event RecorderDRG · Traditional | 10/03/2007SE |
| K071011 | Modification to: Braemar ER900 Series Enhanced Algorithm ECG Event RecorderMWJ · Special | 04/27/2007SE |
| K042469 | Braemar ER800 Series Enhanced Algorithm Event RecorderMWJ · Traditional | 10/06/2004SE |
| K030856 | ER800 Series ECG Event RecorderMWJ · Special | 03/28/2003SE |
| K993618 | DXP1000 Holter RecorderMWJ · Special | 11/24/1999SE |
| K993617 | Digitrakplus Holter RecorderMWJ · Special | 11/24/1999SE |
| K981394 | Braemar ER700 Series Ambulatory ECG Event Monitor Models ER710,ER720DXH · Traditional | 09/28/1998SE |
| K945130 | Braemar Model DL700 Ambulatory Electrocardiographic RecorderDSH · Traditional | 04/12/1995SE |
Questions and answers
When was DL900 Series Holter Recorder cleared by the FDA?
DL900 Series Holter Recorder (K071733) received a 510(k) decision of Substantially Equivalent on July 24, 2007, 28 days after the submission was received.
What is the product code of K071733?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.