Device Classification Name |
Monitor, Breathing Frequency
|
510(k) Number |
K930790 |
Device Name |
ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD. |
Applicant |
BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA |
MUNDELEIN,
IL
60060 -3700
|
|
Applicant Contact |
CATHY BUHNER |
Correspondent |
BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA |
MUNDELEIN,
IL
60060 -3700
|
|
Correspondent Contact |
CATHY BUHNER |
Regulation Number | 868.2375
|
Classification Product Code |
|
Date Received | 02/16/1993 |
Decision Date | 01/06/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|