Device Classification Name |
ventilator, emergency, powered (resuscitator)
|
510(k) Number |
K944397 |
Device Name |
BNOS MICROVENT, MODEL AC AND MODEL AO |
Applicant |
RACAL HEALTH & SAFETY, INC. |
7305 EXECUTIVE WAY |
FREDERICK,
MD
21701
|
|
Applicant Contact |
YUK-TING WU |
Correspondent |
RACAL HEALTH & SAFETY, INC. |
7305 EXECUTIVE WAY |
FREDERICK,
MD
21701
|
|
Correspondent Contact |
YUK-TING WU |
Regulation Number | 868.5925
|
Classification Product Code |
|
Date Received | 09/08/1994 |
Decision Date | 01/31/1995 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|