LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
FDA 510(k) clearance K170565 · decided 2017-08-01
Clearance details
- K-number
- K170565
- Device name
- LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
- Applicant
- Lifewatch Services, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-02-27
- Decision date
- 2017-08-01
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- QYX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rosemont, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RhythmStar System (SL) (K250793) | RhythMedix, LLC | 2026-04-21 |
| Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (K241179) | VivaQuant, Inc. | 2025-07-11 |
| SmartCardia 7L Platform (MCT) (K240653) | Smartcardia SA | 2024-10-31 |
| Zio AT® device (A100A1001) (K240029) | iRhythm Technologies, Inc. | 2024-10-21 |
| RhythmStar System (K233584) | RhythMedix, LLC | 2024-07-08 |
| NOWCARDIO SYSTEM (K162956) | Contex International Technologies (Canada), Inc. | 2017-09-22 |
| Zio AT ECG Monitoring System (K163512) | iRhythm Technologies, Inc. | 2017-06-02 |
| MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (K160064) | Infobionic, Inc. | 2016-03-11 |
| MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR (K133753) | Infobionic, Inc. | 2014-09-19 |
| NUVANT MCT SYSTEM (K133701) | Corventis, Inc. | 2014-02-06 |
| NUVANT, MOBILC CARDIAC TELEMETRY (K113372) | Corventis, Inc. | 2012-03-07 |
| NUVANT, MOBILE CARDIAC TELEMETRY (K111917) | Corventis, Inc. | 2011-08-24 |
Recalls involving this device
No recalls on record reference this clearance.