Device Classification Name |
stethoscope, esophageal, with electrical conductors
|
510(k) Number |
K930929 |
Device Name |
ESOPHAGEAL STETHOSCOPE |
Applicant |
COAST MEDICAL CORP. |
1060 NORTH BATAVIA |
UNIT H |
ORANGE,
CA
92667
|
|
Applicant Contact |
DOUGLAS MONGEON |
Correspondent |
COAST MEDICAL CORP. |
1060 NORTH BATAVIA |
UNIT H |
ORANGE,
CA
92667
|
|
Correspondent Contact |
DOUGLAS MONGEON |
Regulation Number | 868.1920
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/23/1993 |
Decision Date | 03/17/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|