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FDA 510(k) Application Details - K002806
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K002806
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
KATECHO, INC.
2500 BELL AVE.
P.O. BOX 21247
DES MOINES, IA 50321 US
Other 510(k) Applications for this Company
Contact
WARREN R WALTERS
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
09/08/2000
Decision Date
11/21/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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