Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K021716 |
Device Name |
SIMPLIFY COMPACT RESUSCITATOR |
Applicant |
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. |
UNIT B,1-5 F,WAREHOUSE & PROC. |
COMPLEX BLDG. XIANGYU F.T.Z. |
XIAMEN,
CN
|
|
Applicant Contact |
SHAN HUA YING |
Correspondent |
POLYMED (XIAMEN) PLASTIC INDUSTRIAL CO.,LTD. |
UNIT B,1-5 F,WAREHOUSE & PROC. |
COMPLEX BLDG. XIANGYU F.T.Z. |
XIAMEN,
CN
|
|
Correspondent Contact |
SHAN HUA YING |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 05/23/2002 |
Decision Date | 10/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|