Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K983550 |
Device Name |
XYZ SYSTEM |
Applicant |
BIO-MONITORING INTERNATIONAL CORP. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
ANAND AKERKAR |
Correspondent |
BIO-MONITORING INTERNATIONAL CORP. |
55 Northern Blvd. |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
ANAND AKERKAR |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 10/09/1998 |
Decision Date | 01/07/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|