510(k) K212723— BTL-995-rTMS

Substantially Equivalent

BTL Industries, Inc.

Clearance details

Applicant: BTL Industries, Inc.
Product code: Code OBP
Advisory panel: Neurology
Date received: 2021-08-27
Decision date: 2022-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

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.