Device Classification Name |
Device, Temperature Measurement, Direct Contact, Powered
|
510(k) Number |
K822795 |
Device Name |
GABRIEL DIGITREND |
Applicant |
GABRIEL ENT. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
GABRIEL ENT. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 882.1570
|
Classification Product Code |
|
Date Received | 09/16/1982 |
Decision Date | 10/08/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|