Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K140707
Device Classification Name
Ventilator, Emergency, Powered (Resuscitator)
More FDA Info for this Device
510(K) Number
K140707
Device Name
Ventilator, Emergency, Powered (Resuscitator)
Applicant
INTERNATIONAL BIOMEDICAL
8206 CROSS PARK DR.
AUSTIN, TX 78754 US
Other 510(k) Applications for this Company
Contact
AMY PIEPER
Other 510(k) Applications for this Contact
Regulation Number
868.5925
More FDA Info for this Regulation Number
Classification Product Code
BTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/20/2014
Decision Date
05/28/2014
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