Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K073716
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K073716
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
377 ZANE COURT
HILLSIDE VILLAGE
ELIZABETH, CO 80107 US
Other 510(k) Applications for this Company
Contact
ALEX HENDERSON
Other 510(k) Applications for this Contact
Regulation Number
870.5310
More FDA Info for this Regulation Number
Classification Product Code
MKJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/31/2007
Decision Date
04/11/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact