510(k) K230358
- Device
- SAVI Dual (TM) Migraine Therapy
- Applicant
- Eneura, Inc.
- 510(k) number
- K230358
- Product code
- OKP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-16
- Date received
- 2023-02-10
- Regulation
- 882.5808
- Classification name
- Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David Rosen
- Address
- 101 W. Dickman St. Suite 900 Baltimore MD US 21230 21230
FDA Registration Numbers#
- 3008487930
- 3015259858
Source Documents#
Other 510(k) Records For Product Code OKP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182976 | SpringTMS | Eneura®, Inc. | 2019-02-25 |
| K162797 | SpringTMS | Eneura, Inc. | 2017-06-26 |
| K161663 | sTMS mini | Eneura, Inc. | 2016-08-23 |
| K140094 | SPRINGTMS TOTAL MIGRAINE SYSTEM | Eneura Therapeutics, LLC | 2014-05-21 |
| DEN130022 | NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR | Eneura Therapeutics | 2013-12-13 |