ARIA
FDA 510(k) clearance K001317 · decided 2000-07-21
Clearance details
- K-number
- K001317
- Device name
- ARIA
- Applicant
- Del Mar Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2000-04-26
- Decision date
- 2000-07-21
- Days to decision
- 86 days
- Clearance type
- Abbreviated
- Product code
- MWJ
- Device class
- 2
- Regulation number
- 870.2800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| ZywieZ3 Sensor & Adhesive (K252839) | Zywie, Inc. | 2026-06-18 |
| HeartBeam AIMIGo(TM) System (K231424) | Heartbeam, Inc. | 2024-12-13 |
| 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.