NUVANT MCT SYSTEM— 510(k) K133701
Substantially EquivalentCorventis, Inc.
FDA 510(k) clearance K133701 for NUVANT MCT SYSTEM, Substantially Equivalent on 2014-02-06. Applicant: Corventis, Inc.. Device class: 2.
Clearance details
- Applicant
- Corventis, Inc.
- Product code
- Code QYX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Paul, MN, US
Recent devices under product code QYX
view allMore clearances from Corventis, Inc.
view all- K113372 — NUVANT, MOBILC CARDIAC TELEMETRY
- K113187 — AVIVO MOBILE PATIENT MANAGEMENT
- K111917 — NUVANT, MOBILE CARDIAC TELEMETRY
- K091971 — AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM
- K090696 — NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM
Adverse events under product code QYX
product code QYX- Death
- 13
- Malfunction
- 526
- Total
- 539
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.