The following data is part of a premarket notification filed by Eneura® Inc. with the FDA for Springtms.
Device ID | K182976 |
510k Number | K182976 |
Device Name: | SpringTMS |
Classification | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache |
Applicant | eNeura® Inc. 715 North Pastoria Avenue Sunnyvale, CA 94085 |
Contact | David Rosen |
Correspondent | Larry W. Getlin Larry W. Getlin 2690 Pheasant Road Orono, MN 55331 |
Product Code | OKP |
CFR Regulation Number | 882.5808 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-10-26 |
Decision Date | 2019-02-25 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPRINGTMS 85035243 4010226 Live/Registered |
ENEURA, INC. 2010-05-11 |