NUVANT MCT SYSTEM
FDA 510(k) clearance K133701 · decided 2014-02-06
Clearance details
- K-number
- K133701
- Device name
- NUVANT MCT SYSTEM
- Applicant
- Corventis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-12-03
- Decision date
- 2014-02-06
- Days to decision
- 65 days
- Clearance type
- Special
- Product code
- QYX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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| NOWCARDIO SYSTEM (K162956) | Contex International Technologies (Canada), Inc. | 2017-09-22 |
| LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (K170565) | Lifewatch Services, Inc. | 2017-08-01 |
| 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, 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.