Device Classification Name |
stethoscope, esophageal
|
510(k) Number |
K860558 |
Device Name |
ESOPHAGEAL STETHOSCOPE |
Applicant |
SHARN, INC. |
1300 NORTH WESTSHORE BLVD. |
TAMPA,
FL
33607
|
|
Applicant Contact |
BRUCE A TOMLINSON |
Correspondent |
SHARN, INC. |
1300 NORTH WESTSHORE BLVD. |
TAMPA,
FL
33607
|
|
Correspondent Contact |
BRUCE A TOMLINSON |
Regulation Number | 868.1910
|
Classification Product Code |
|
Date Received | 02/14/1986 |
Decision Date | 04/01/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|