VITERION 100 TELEHEALTH MONITOR— 510(k) K030419
Substantially EquivalentViterion Telehealthcare, LLC
FDA 510(k) clearance K030419 for VITERION 100 TELEHEALTH MONITOR, Substantially Equivalent on 2003-11-06. Applicant: Viterion Telehealthcare, LLC. Device class: 2.
Clearance details
- Applicant
- Viterion Telehealthcare, LLC
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
Recent devices under product code MWI
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
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 →
Recalls naming K030419
K-number listed on FDA's recall record- Z-0820-2013 — Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
- Z-0821-2013 — Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030419.
Data sourced from openFDA. This site is unofficial and independent of the FDA.