Device Classification Name |
tube, tracheal (w/wo connector)
|
510(k) Number |
K951768 |
Device Name |
TEVES ECM PLUS THERMOCOUPLE |
Applicant |
ADVANCED MEDICAL CONCEPTS, INC. |
623 39TH ST. WEST |
BRADENTON,
FL
34205
|
|
Applicant Contact |
LORNA K LINVILLE |
Correspondent |
ADVANCED MEDICAL CONCEPTS, INC. |
623 39TH ST. WEST |
BRADENTON,
FL
34205
|
|
Correspondent Contact |
LORNA K LINVILLE |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 04/17/1995 |
Decision Date | 12/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|