Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K180173 |
Device Name |
Freespira |
Applicant |
Palo Alto Health Sciences, Inc. |
12020 113th Ave NE, Building C, Suite 215 |
Kirkland,
WA
98034
|
|
Applicant Contact |
Simon Thomas |
Correspondent |
AcKnowledge Regulatory Strategies, LLC |
2834 Hawthorn St. |
San Diego,
CA
92104
|
|
Correspondent Contact |
Allison Komiyama |
Regulation Number | 882.5050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/22/2018 |
Decision Date | 08/23/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|