Device Classification Name |
Ventilator, Emergency, Manual (Resuscitator)
|
510(k) Number |
K032596 |
Device Name |
STURDY MANUAL RESUSCITATOR |
Applicant |
STURDY INDUSTRIAL CO., LTD |
6833 SAINT LAWRENCE STREET |
PLANO,
TX
75024
|
|
Applicant Contact |
ERIC LUO |
Correspondent |
STURDY INDUSTRIAL CO., LTD |
6833 SAINT LAWRENCE STREET |
PLANO,
TX
75024
|
|
Correspondent Contact |
ERIC LUO |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 08/22/2003 |
Decision Date | 08/05/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|