FDA.reportPublic FDA data

510(k) K062119

Device
HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
Applicant
Medical Products Mfg., LLC
510(k) number
K062119
Product code
DRM
Decision
Substantially Equivalent (SESE)
Decision date
2006-09-22
Date received
2006-07-25
Regulation
870.5200
Classification name
Compressor, Cardiac, External
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
ROSINA ROBINSON
Address
49 Plain St. North Attleboro MA US 02760 02760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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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
K053403LUCASJolife AB2006-02-01
K024215ENERTRON CPR JACKEnertron Engineering Co.2004-05-14