K222010

Substantially Equivalent

Biobeat Platform-2 and BB-613WP Patch

Applicant: Biobeat Technologies , Ltd.
Product code: DQA
Advisory panel: Cardiovascular
Date received: 2022-07-07
Decision date: 2022-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petah Tikvah, IL

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.