VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY)— 510(k) K141167
Substantially EquivalentVitalconnect, Inc.
FDA 510(k) clearance K141167 for VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SOFTWARE LIBRARY), Substantially Equivalent on 2014-07-29. Applicant: Vitalconnect, Inc.. Device class: 2.
Clearance details
- Applicant
- Vitalconnect, Inc.
- Product code
- 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
- Campbell, CA, US
Recent devices under product code DRG
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view all- K242129 — VitalRhythm
- K193343 — Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
- 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
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.