Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K042556 |
Device Name |
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, |
Applicant |
ENTER MEDICAL CORPORATION |
NO.16-1, LANE 564 |
WEN HUA SAN ROAD |
GUI SHAN XIANG,TAO YUAN HSIEN,
TW
333
|
|
Applicant Contact |
TZONG-FUH KUO |
Correspondent |
ENTER MEDICAL CORPORATION |
NO.16-1, LANE 564 |
WEN HUA SAN ROAD |
GUI SHAN XIANG,TAO YUAN HSIEN,
TW
333
|
|
Correspondent Contact |
TZONG-FUH KUO |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 09/20/2004 |
Decision Date | 03/11/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|