Device Classification Name |
amplifier, physiological signal
|
510(k) Number |
K203331 |
Device Name |
Quick-20m |
Applicant |
CGX, LLC |
8445 Camino Sante Fe, Suite 104 |
San Diego,
CA
92121
|
|
Applicant Contact |
Spencer Linton |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 882.1835
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/12/2020 |
Decision Date | 05/20/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|