FDA.reportPublic FDA data

510(k) K855004

Device
SWELL-RELIEF
Applicant
D.A. SCHULMAN, INC.
510(k) number
K855004
Product code
DRM  
Decision
Substantially Equivalent (SESE)
Decision date
1986-02-12
Date received
1985-12-13
Regulation
870.5200
Classification name
Compressor, Cardiac, External
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID A SCHULMAN
Address
7701 Newton Ave. N. Brooklyn Park MN US 55444 55444

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DRM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221700AutoPulse NXT Resuscitation SystemZoll Circulation, Inc.2023-03-09
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases