DR180-II
FDA 510(k) clearance K001288 · decided 2000-07-20
Clearance details
- K-number
- K001288
- Device name
- DR180-II
- Applicant
- North East Monitoring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-04-24
- Decision date
- 2000-07-20
- Days to decision
- 87 days
- Clearance type
- Abbreviated
- Product code
- MWJ
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sudbury, MA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| ASSURE Wearable ECG (K233864) | Kestra Medical Technologies, Inc. | 2024-05-07 |
| Eclipse MINI Model 98900 (K212317) | Spacelabs Healthcare, Ltd. | 2022-11-07 |
| Biotres (K222017) | Biotricity | 2022-07-28 |
| Q Patch (K210758) | Medicalgorithmics S.A. | 2022-06-02 |
| Biotres (K211709) | Biotricity | 2022-01-19 |
| Eclipse PRO (K211651) | Spacelabs Healthcare, Ltd. | 2021-11-22 |
| Integrated CardioRespiratory System (K173156) | Sensydia, Inc. | 2018-06-08 |
| NR Recorder (K161062) | Norav Medical GmbH | 2016-06-13 |
| H3+ Holter Recorder (K152626) | Mortara Instrument, Inc. | 2016-02-26 |
Recalls involving this device
No recalls on record reference this clearance.