510(k) K071733 ยท MWJ Electrocardiograph, Ambulatory (Without Analysis)
DL900 SERIES HOLTER RECORDER
| Applicant | Braemar, Inc., Eagan MN, US |
| Decision | Substantially Equivalent, Jul 24, 2007 |
| Received | Jun 26, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071733
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2020 | Braemar Manufacturing, LLC Braemar Manufacturing LLC
DL900 Holter Monitor
1285 Corporate Center Dr.
Suite 150
Eagan, MN 55121 USA
Rx Only Terminated |
MWJ | None listed |
| Jan 22, 2020 | Braemar Manufacturing, LLC Braemar Manufacturing LLC
DL950 Holter Monitor
1285 Corporate Center Dr.
Suite 150
Eagan, MN 55121 USA
Rx Only Terminated |
MWJ | None listed |
| Jan 13, 2020 | Philips North America, LLC 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 fol Terminated |
MWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.