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FDA 510(k) Application Details - K955854
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K955854
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND, WA 98073-9706 US
Other 510(k) Applications for this Company
Contact
SHERRI L POCOCK
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
12/28/1995
Decision Date
11/04/1996
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
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