Device Classification Name |
Support, Breathing Tube
|
510(k) Number |
K834265 |
Device Name |
TRACH MATE |
Applicant |
TEMPE BIOMEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
TEMPE BIOMEDICAL, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5280
|
Classification Product Code |
|
Date Received | 12/08/1983 |
Decision Date | 01/04/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|