FDA 510(k), K230358, SAVI Dual (TM) Migraine Therapy

510(K) Number: K230358
Device Name: SAVI Dual (TM) Migraine Therapy
Manufacturer: David Rosen
Device Classification Name: Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
Regulation Number: OKP
Classification Product Code: KXA
Date Received: 02/10/2023
Decision Date: 05/16/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology

Content Pages: 647 (122 of 769 original pages are fully redacted)