Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K970959 |
Device Name |
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) |
Applicant |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Applicant Contact |
LORI ZURAVLEFF |
Correspondent |
INSTRUMENTATION INDUSTRIES, INC. |
2990 INDUSTRIAL BLVD. |
BETHEL PARK,
PA
15102
|
|
Correspondent Contact |
LORI ZURAVLEFF |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 03/17/1997 |
Decision Date | 06/13/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|