Device Classification Name |
oximeter
|
510(k) Number |
K874692 |
Device Name |
PULSEMATE BX-5 |
Applicant |
COLIN MEDICAL INSTRUMENTS CORP. |
1330 CONNECTICUT AVENUE, N.W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
EDWARD M LEBOW |
Correspondent |
COLIN MEDICAL INSTRUMENTS CORP. |
1330 CONNECTICUT AVENUE, N.W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
EDWARD M LEBOW |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 11/16/1987 |
Decision Date | 02/02/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|