Panels › Cardiovascular › Product code MWJ · Class 2
Electrocardiograph, Ambulatory (Without Analysis)
Regulation 870.2800
5510(k)s in 12 months (64 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in MWJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2024 | Spacelabs Healthcare, Ltd. Eclipse Mini REF 98900
The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram. Open, Classified |
MWJ | K212317 |
| Dec 17, 2024 | Spacelabs Healthcare, Ltd. Eclipse PRO REF 98700
The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram. Open, Classified |
MWJ | K211651 |
| 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 | K071733 |
| 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 | K071733 |
| 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 | K071733 |
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