Device Classification Name |
Stethoscope, Esophageal, With Electrical Conductors
|
510(k) Number |
K973839 |
Device Name |
DISPOSABLE ESOPHAGEAL STETHOSCOPE |
Applicant |
CATHETER RESEARCH, INC. |
6131 WEST 80TH ST. |
INDIANAPOLIS,
IN
46278
|
|
Applicant Contact |
JOHN A STEEN, PH.D. |
Correspondent |
CATHETER RESEARCH, INC. |
6131 WEST 80TH ST. |
INDIANAPOLIS,
IN
46278
|
|
Correspondent Contact |
JOHN A STEEN, PH.D. |
Regulation Number | 868.1920
|
Classification Product Code |
|
Date Received | 10/08/1997 |
Decision Date | 03/19/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|