FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVANT, MOBILE CARDIAC TELEMETRY
K Number: K111917
·
Decision Aug 24, 2011
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
20
Applicant Total
7
Review Days
49
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NUVANT, MOBILE CARDIAC TELEMETRY
- K Number
- K111917
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corventis, Inc.
- Date Received
- July 6, 2011
- Decision Date
- August 24, 2011
- Product Code
- QYX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QYX | Outpatient Cardiac Telemetry | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QYX), ordered by most recent decision date.
RhythmStar System (SL)
FDA 510(k)
FDA Class 2
·Cardiovascular
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
FDA 510(k)
FDA Class 2
·Cardiovascular
SmartCardia 7L Platform (MCT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Zio AT® device (A100A1001)
FDA 510(k)
FDA Class 2
·Cardiovascular
RhythmStar System
FDA 510(k)
FDA Class 2
·Cardiovascular
NOWCARDIO SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Corventis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133701 | NUVANT MCT SYSTEM | Feb 6, 2014 | Substantially Equivalent |
| K113372 | NUVANT, MOBILC CARDIAC TELEMETRY | Mar 7, 2012 | Substantially Equivalent |
| K113187 | AVIVO MOBILE PATIENT MANAGEMENT | Jan 4, 2012 | Substantially Equivalent |
| K091971 | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM | Aug 27, 2009 | Substantially Equivalent |
| K090696 | NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM | Jun 19, 2009 | Substantially Equivalent |
| K083287 | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM | Feb 3, 2009 | Substantially Equivalent |