Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K083656
Device Classification Name
Ventilator, Non-Continuous (Respirator)
More FDA Info for this Device
510(K) Number
K083656
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
APEX MEDICAL CORP.
NO. 9, MINSHENG STREET
TUCHENG CITY, TAIPEI COUNTY 236 TW
Other 510(k) Applications for this Company
Contact
ALAN CHANG
Other 510(k) Applications for this Contact
Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
BZD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2008
Decision Date
04/22/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact