COBRA-OS Kit— 510(k) K201652

Unknown

Front Line Medical Technologies, Inc.

FDA 510(k) clearance K201652 for COBRA-OS Kit, Unknown on 2021-02-22. Applicant: Front Line Medical Technologies, Inc..

Clearance details

Applicant: Front Line Medical Technologies, Inc.
Product code: Code MJN
Advisory panel: Cardiovascular
Date received: 2020-06-18
Decision date: 2021-02-22
Decision: Unknown
Clearance type: Traditional
Location: London, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.