Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K913900 |
Device Name |
V*CARE MANUAL RESUSCITATOR, CAT#VR-1000 |
Applicant |
VENTLAB CORP. |
BUILDING 14E EASY ST. |
P.O. BOX 244 |
BOUND BROOK,
NJ
08805
|
|
Applicant Contact |
GREGORY LAU |
Correspondent |
VENTLAB CORP. |
BUILDING 14E EASY ST. |
P.O. BOX 244 |
BOUND BROOK,
NJ
08805
|
|
Correspondent Contact |
GREGORY LAU |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 08/30/1991 |
Decision Date | 01/07/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|