Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K770629 |
Device Name |
VALVE, EXHALATION BE 115-4, 115-5 |
Applicant |
INSTRUMENTATION INDUSTRIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
INSTRUMENTATION INDUSTRIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 04/04/1977 |
Decision Date | 05/23/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|