VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System— 510(k) K173140

Clearance details

Applicant

Vivachek Laboratories, Inc.

Product code

Product code NBW

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2017-09-29

Decision date

2018-12-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wilmington, DE, US

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• K160179 — VivaChek Ino Blood Glucose Monitoring System2017-04-21

Death

18

Injury

4,740

Malfunction

42,679

Other

6

Total

47,443

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →