Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K131877
Device Classification Name
Ventilator, Emergency, Powered (Resuscitator)
More FDA Info for this Device
510(K) Number
K131877
Device Name
Ventilator, Emergency, Powered (Resuscitator)
Applicant
AUTOMEDX INC.
1420 Lakeside Parkway, Suite 102
Flower Mound, TX 75028 US
Other 510(k) Applications for this Company
Contact
PAUL DRYDEN
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
06/25/2013
Decision Date
03/21/2014
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