Device Classification Name |
stethoscope, esophageal, with electrical conductors
|
510(k) Number |
K841098 |
Device Name |
SHERIDAN YSI/SONATEMP |
Applicant |
SHERIDAN CATHETER CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
SHERIDAN CATHETER CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 868.1920
|
Classification Product Code |
|
Date Received | 03/13/1984 |
Decision Date | 04/30/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|