Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K823408 |
Device Name |
BE#1000-INSTANT ON/OFF O2 VALVE |
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 | 868.5915
|
Classification Product Code |
|
Date Received | 11/15/1982 |
Decision Date | 12/07/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|