Product code MWJ
- Device name
- Electrocardiograph, Ambulatory (Without Analysis)
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2800
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231424 | HeartBeam AIMIGo(TM) System | Heartbeam, Inc. | 2024-12-13 |
| K233864 | ASSURE Wearable ECG | Kestra Medical Technologies, Inc. | 2024-05-07 |
| K212317 | Eclipse MINI Model 98900 | Spacelabs Healthcare, Ltd. | 2022-11-07 |
| K222017 | Biotres | Biotricity | 2022-07-28 |
| K210758 | Q Patch | Medicalgorithmics S.A. | 2022-06-02 |
| K211709 | Biotres | Biotricity | 2022-01-19 |
| K211651 | Eclipse PRO | Spacelabs Healthcare, Ltd. | 2021-11-22 |
| K173156 | Integrated CardioRespiratory System | Sensydia, Inc. | 2018-06-08 |
| K161062 | NR Recorder | Norav Medical GmbH | 2016-06-13 |
| K152626 | H3+ Holter Recorder | Mortara Instrument, Inc. | 2016-02-26 |
| K142424 | DR300 HOLTER MONITOR | North East Monitoring, Inc. | 2014-11-25 |
| K133014 | DMS 300-2W HOLTER ECG RECORDER | Diagnostic Monitoring Software | 2014-05-19 |
| K130294 | BRAEMAR CARDIOKEY HOLTER RECORDER | Braemar Manufacturing, LLC | 2013-10-16 |
| K130785 | SEER 1000 | Getemed Medizin- Und Informationstechnik AG | 2013-07-26 |
| K122272 | CARDIOMEM | Getemed Medizin- Und Informationstechnik AG | 2013-03-28 |
| K112573 | EZSLEEP SLEEP QUALITY RECORDER | Platinum Team Co., Ltd. | 2012-03-22 |
| K112601 | INTRICON DATRIX SIRONA EVENT/ HOLTER RECORDER | Intricon Datrix Corporation | 2011-11-09 |
| K101969 | MH1 MICROHOLTER RECORDER | Exelys, LLC | 2011-02-04 |
| K101024 | KENZ CARDY302 MAX | Suzuken Co., Ltd. | 2011-01-06 |
| K102723 | MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS | Memtec Corp. | 2010-12-09 |
| K100310 | BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS | BTL Industries, Inc. | 2010-10-13 |
| K100266 | ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 | Camntech, Ltd. | 2010-04-29 |
| K083382 | CHROMA, MODEL: RZ153C | Scottcare Corporation | 2009-08-13 |
| K091054 | WALK400H | Et Medical Devices Spa | 2009-07-27 |
| K073545 | AUDICOR, HEMO AMBULATORY MONITOR | Inovise Medical, Inc. | 2008-09-09 |
| K071085 | E3-80 PORTABLE ECG RECORDER & ANALYZER | Micro-Star International Co., Ltd. | 2007-10-03 |
| K071733 | DL900 SERIES HOLTER RECORDER | Braemar, Inc. | 2007-07-24 |
| K063042 | CARDIOMEM CM 3000-12BT | Getemed Medizin- Und Informationstechnik AG | 2007-05-30 |
| K070014 | AUTO DETECT FOR TELAHEART DR200/E-A | North East Monitoring, Inc. | 2007-05-25 |
| K071011 | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER | Braemar, Inc. | 2007-04-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10841522131400 | Eclipse Pro | SPACELABS HEALTHCARE (WASHINGTON), INC | 2025-10-09 |
| 10841522131394 | Eclipse Pro | SPACELABS HEALTHCARE (WASHINGTON), INC | 2025-10-09 |
| 10841522131387 | Eclipse Pro | SPACELABS HEALTHCARE (WASHINGTON), INC | 2025-10-09 |
| 10841522131363 | Eclipse Pro | SPACELABS HEALTHCARE (WASHINGTON), INC | 2025-10-09 |
| 10841522131356 | Eclipse Pro | SPACELABS HEALTHCARE (WASHINGTON), INC | 2025-10-09 |
| 10841522131349 | Eclipse Pro | SPACELABS HEALTHCARE (WASHINGTON), INC | 2025-10-09 |
| 10841522131370 | Eclipse Pro | SPACELABS HEALTHCARE (WASHINGTON), INC | 2025-10-01 |
| G2331000010 | SansaTM | Huxley Medical, Inc. | 2024-10-21 |
| G2331000020 | SansaTM | Huxley Medical, Inc. | 2024-10-21 |
| G2331000000 | SansaTM | Huxley Medical, Inc. | 2024-10-21 |
| 10841522125492 | EVO | SPACELABS HEALTHCARE (WASHINGTON), INC | 2024-04-22 |
| B353AB12571 | Advance Biometrix | Lifesignals, Inc. | 2021-08-26 |
| B353AB12511 | Advance Biometrix | Lifesignals, Inc. | 2021-08-26 |
| B353CV12531 | CorVitals | Lifesignals, Inc. | 2021-05-14 |
| B353CV12451 | CORVITALS | Lifesignals, Inc. | 2020-06-26 |
| 10841522125485 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-12-31 |
| 10841522125331 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125324 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125317 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125300 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125294 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125270 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125256 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125232 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125218 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125195 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125188 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-29 |
| 10841522125461 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-10 |
| 10841522125478 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2018-08-10 |
| 10812345026020 | Holter Prep Kit | MORTARA INSTRUMENT, INC. | 2016-09-24 |