Device Classification Name |
stethoscope, esophageal, with electrical conductors
|
510(k) Number |
K904943 |
Device Name |
TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE |
Applicant |
ARZCO MEDICAL ELECTRONICS, INC. |
1029 BUTTERFIELD RD. |
(DUPLICATE/1927197) |
VERNON HILLS,
IL
60061
|
|
Applicant Contact |
RICHARD M BILOF |
Correspondent |
ARZCO MEDICAL ELECTRONICS, INC. |
1029 BUTTERFIELD RD. |
(DUPLICATE/1927197) |
VERNON HILLS,
IL
60061
|
|
Correspondent Contact |
RICHARD M BILOF |
Regulation Number | 868.1920
|
Classification Product Code |
|
Date Received | 11/01/1990 |
Decision Date | 04/26/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|