DL900 SERIES HOLTER RECORDER— 510(k) K071733
Substantially EquivalentBraemar, Inc.
FDA 510(k) clearance K071733 for DL900 SERIES HOLTER RECORDER, Substantially Equivalent on 2007-07-24. Applicant: Braemar, Inc.. Device class: 2.
Clearance details
- Applicant
- Braemar, Inc.
- Product code
- Code MWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Eagan, MN, US
Recent devices under product code MWJ
view allMore clearances from Braemar, Inc.
view allAdverse events under product code MWJ
product code MWJ- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K071733
K-number listed on FDA's recall record- Z-1459-2020 — Braemar Manufacturing LLC DL900 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
- Z-1460-2020 — Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
- Z-1345-2020 — Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Configuration - 453564067171 96-Hour Configuration - 453564067181 7-Day Configuration Model Number: 860322
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071733.
Data sourced from openFDA. This site is unofficial and independent of the FDA.