Device Classification Name |
Stethoscope, Esophageal, With Electrical Conductors
|
510(k) Number |
K821890 |
Device Name |
CRITIKON #817 ESOPHAGEAL MULTI-PROBE |
Applicant |
CRITIKON COMPANY,LLC |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
CRITIKON COMPANY,LLC |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.1920
|
Classification Product Code |
|
Date Received | 06/25/1982 |
Decision Date | 08/03/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|