510(k) 510AANDNOA
- Device
- CARDTEL, MODEL NT-100
- Applicant
- CARDIAC TELECOMMUNICATIONS
- 510(k) number
- 510AANDNOA
- Product code
- MWJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-05-23
- Date received
- 2000-02-23
- Regulation
- 870.2800
- Classification name
- Electrocardiograph, Ambulatory (without Analysis)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code MWJ #
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases