BioButton System— 510(k) K212957

Substantially Equivalent

Biolntellisense, Inc.

FDA 510(k) clearance K212957 for BioButton System, Substantially Equivalent on 2022-12-12. Applicant: Biolntellisense, Inc..

Clearance details

Applicant: Biolntellisense, Inc.
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2021-09-16
Decision date: 2022-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.