MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM— 510(k) K901613

Substantially Equivalent

Medisense, Inc.

FDA 510(k) clearance K901613 for MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM, Substantially Equivalent on 1990-07-10. Applicant: Medisense, Inc..

Clearance details

Applicant: Medisense, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 1990-04-06
Decision date: 1990-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

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Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.