FDA.reportPublic FDA data

510(k) K221700

Device
AutoPulse NXT Resuscitation System
Applicant
Zoll Circulation, Inc.
510(k) number
K221700
Product code
DRM
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-09
Date received
2022-06-13
Regulation
870.5200
Classification name
Compressor, Cardiac, External
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brian Robey
Address
2000 Ringwood Ave. San Jose CA US 95131 95131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DRM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC2021-11-09
K173553LUCAS 3 Chest Compression SystemJolife AB2018-02-08
K161768LUCAS 3 Chest Compression SystemJolife AB2016-11-09
K153628ROSC-U Mini Chest Compressor (RMCC)Resuscitation International, LLC2016-01-30
K141809RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEMDefibtech, LLC2014-10-27
K112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000Zoll Circulation2012-03-15
K102068MINIATURIZE CHEST COMPRESSOR (MCC)Resuscitation International2010-11-16
K090422LUCAS 2Jolife AB2009-06-17
K072527AUTOPULSE RESUSCITATION SYSTEM, MODEL 100Zoll Circulation2008-03-19
K073079THUMPER, MODEL: 1008Michigan Instruments, Inc.2008-02-14
K063602AUTOPULSE RESUSCITATION SYSTEM MODEL100Zoll Circulation2006-12-21
K062401MODIFICATION TO LUCASJolife AB2006-09-28
K062119HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100Medical Products Mfg., LLC2006-09-22
K053403LUCASJolife AB2006-02-01
K024215ENERTRON CPR JACKEnertron Engineering Co.2004-05-14