FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVANT, MOBILC CARDIAC TELEMETRY
K Number: K113372
·
Decision Mar 7, 2012
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
20
Applicant Total
7
Review Days
112
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Basic Information
- Device Name
- NUVANT, MOBILC CARDIAC TELEMETRY
- K Number
- K113372
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corventis, Inc.
- Date Received
- November 16, 2011
- Decision Date
- March 7, 2012
- 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 |
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Other Clearances by Corventis, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133701 | NUVANT MCT SYSTEM | Feb 6, 2014 | Substantially Equivalent |
| K113187 | AVIVO MOBILE PATIENT MANAGEMENT | Jan 4, 2012 | Substantially Equivalent |
| K111917 | NUVANT, MOBILE CARDIAC TELEMETRY | Aug 24, 2011 | 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 |