Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K970158 |
Device Name |
BABYPAC |
Applicant |
PNEUPAC, INC. |
P.O. BOX 973 |
WAKE FOREST,
NC
27588
|
|
Applicant Contact |
NORMAN GRAY |
Correspondent |
PNEUPAC, INC. |
P.O. BOX 973 |
WAKE FOREST,
NC
27588
|
|
Correspondent Contact |
NORMAN GRAY |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 01/16/1997 |
Decision Date | 04/28/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|