Device Classification Name |
Stethoscope, Esophageal, With Electrical Conductors
|
510(k) Number |
K862672 |
Device Name |
ESOPHAGEAL STETHOSCOPE WITH THERMISTOR |
Applicant |
INMED CORP. |
3030-B HOLCOMB BRIDGE RD. |
NORCROSS,
GA
30071
|
|
Applicant Contact |
BLACKWOOD HYAMS |
Correspondent |
INMED CORP. |
3030-B HOLCOMB BRIDGE RD. |
NORCROSS,
GA
30071
|
|
Correspondent Contact |
BLACKWOOD HYAMS |
Regulation Number | 868.1920
|
Classification Product Code |
|
Date Received | 07/14/1986 |
Decision Date | 10/27/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|