Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)— 510(k) K193343
Substantially EquivalentVitalconnect, Inc.
FDA 510(k) clearance K193343 for Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed), Substantially Equivalent on 2020-04-20. Applicant: Vitalconnect, Inc.. Device class: 2.
Clearance details
- Applicant
- Vitalconnect, Inc.
- Product code
- Product code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code DRG
view allMore clearances from Vitalconnect, Inc.
view all- K242129 — VitalRhythm
- K192757 — VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20
- K190916 — VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20
- K183078 — VitalConnect Platform, VitalPatch Biosensor
- K163453 — VitalPatch® VitalConnect Platform
Adverse events under product code DRG
product code DRG- Death
- 5
- Total
- 5
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 K193343
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193343.
Data sourced from openFDA. This site is unofficial and independent of the FDA.