Device Classification Name |
Stethoscope, Esophageal, With Electrical Conductors
|
510(k) Number |
K961060 |
Device Name |
ARISTO ESOPHAGEAL STETHOSCOPE |
Applicant |
ARISTO MEDICAL PRODUCTS, INC. |
P.O. BOX 1637 |
WAUKESHA,
WI
53187 -2345
|
|
Applicant Contact |
STEPHEN H GORSKI |
Correspondent |
ARISTO MEDICAL PRODUCTS, INC. |
P.O. BOX 1637 |
WAUKESHA,
WI
53187 -2345
|
|
Correspondent Contact |
STEPHEN H GORSKI |
Regulation Number | 868.1920
|
Classification Product Code |
|
Date Received | 03/18/1996 |
Decision Date | 06/19/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|