Autopulse, Model 100

FDA 510(k) K011046 · Revivant Corp.

Substantially Equivalent

510(k) numberK011046

Submission

Device name
Autopulse, Model 100
Applicant
Revivant Corp.
Sunnyvale, CA, US
Received
April 6, 2001
Decision date
October 25, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DRM – Compressor, Cardiac, External
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5200
Specialty
Cardiovascular

Other 510(k)s with product code DRM

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K221700AutoPulse NXT Resuscitation SystemDRM · Traditional Zoll Circulation, Inc.03/09/2023SE
K211289RMU-2000 Automated Chest Compression SystemDRM · Traditional Defibtech, LLC11/09/2021SE
K173553LUCAS 3 Chest Compression SystemDRM · Traditional Jolife AB02/08/2018SE
K161768LUCAS 3 Chest Compression SystemDRM · Traditional Jolife AB11/09/2016SE
K153628ROSC-U Mini Chest Compressor (RMCC)DRM · Traditional Resuscitation International, LLC01/30/2016SE
K141809RMU-1000 Automated Chest Compression SystemDRM · Traditional Defibtech, LLC10/27/2014SE
K112998Autopulse Resuscitation System Model 1000DRM · Traditional Zoll Circulation03/15/2012SE
K102068Miniaturize Chest Compressor (MCC)DRM · Traditional Resuscitation International11/16/2010SE
K090422Lucas 2DRM · Traditional Jolife AB06/17/2009SE
K072527Autopulse Resuscitation System, Model 100DRM · Traditional Zoll Circulation03/19/2008SE

More from Zoll Circulation

510(k)DeviceDecision
K040453Autopulse Resuscitation System, Model 100DRM · Special 03/11/2004SE
K032852Modification to: Autopulse Resuscitation System Model 100DRM · Special 11/12/2003SE
K022345Autopulse Resuscitation SystemDRM · Special 08/15/2002SE

Questions and answers

When was Autopulse, Model 100 cleared by the FDA?

Autopulse, Model 100 (K011046) received a 510(k) decision of Substantially Equivalent on October 25, 2001, 202 days after the submission was received.

What is the product code of K011046?

The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.