FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
K Number: K083287
·
Decision Feb 3, 2009
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
7
Review Days
88
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Basic Information
- Device Name
- AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
- K Number
- K083287
- 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
- November 7, 2008
- Decision Date
- February 3, 2009
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 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 |
| K113372 | NUVANT, MOBILC CARDIAC TELEMETRY | Mar 7, 2012 | 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 |