GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System— 510(k) K193340

Substantially Equivalent

Microtech Medical, Inc.

FDA 510(k) clearance K193340 for GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System, Substantially Equivalent on 2020-09-11. Applicant: Microtech Medical, Inc..

Clearance details

Applicant: Microtech Medical, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2019-12-02
Decision date: 2020-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NBW

product code NBW

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.