Mag Vita TMS Therapy System w/Theta Burst Stimulation— 510(k) K173620

Substantially Equivalent

Tonica Elektronik A/S

FDA 510(k) clearance K173620 for Mag Vita TMS Therapy System w/Theta Burst Stimulation, Substantially Equivalent on 2018-08-14. Applicant: Tonica Elektronik A/S.

Clearance details

Applicant
Tonica Elektronik A/S
Product code
Code OBP
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Farum, DK
Download summary PDFView on FDA.gov ↗

Adverse events under product code OBP

product code OBP
Injury
270
Total
270

Source: openFDA MAUDE database, through . 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.