Device Classification Name |
Nystagmograph
|
510(k) Number |
K182214 |
Device Name |
DizzyDoctor System 1.0.0 |
Applicant |
DizzyDoctor Systems, LLC |
7625 Mesa College Drive, Suite 200A |
San Diego,
CA
92111
|
|
Applicant Contact |
Ian Purcell |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Mark Job |
Regulation Number | 882.1460
|
Classification Product Code |
|
Date Received | 08/15/2018 |
Decision Date | 09/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|