Atlas FDA

DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P

FDA 510(k) clearance K033896 · decided 2004-06-16

Clearance details

K-number
K033896
Device name
DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
Applicant
Defibtech, LLC
Decision
Substantially Equivalent
Date received
2003-12-16
Decision date
2004-06-16
Days to decision
183 days
Clearance type
Traditional
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Guilford, CT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 recall (Z-2064-2011)Defibtech, LLC2011-05-16

PMA approvals by this applicant

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Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E (P160032/S013)Defibtech, LLC2025-07-03
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Defibtech Automated External Defibrillator (AED) Systems (P160032/S010)Defibtech, LLC2021-09-10
Defibtech's Automated External Defibrillator (AED) System (P160032/S005)Defibtech, LLC2021-06-10
Defibtech Automated External Defibrillator (AED) Systems (P160032/S002)Defibtech, LLC2021-02-25
Defibtech Automated External Defibrillator (AED) Systems (P160032/S003)Defibtech, LLC2020-11-18
Defibtech Automated External Defibrillator (AED) Systems (P160032/S009)Defibtech, LLC2020-10-23