Oxy-Quik Mark IV Oxygen Inhalator

FDA 510(k) K811987 · Oxequip Health Ind.

Substantially Equivalent

510(k) numberK811987

Submission

Device name
Oxy-Quik Mark IV Oxygen Inhalator
Applicant
Oxequip Health Ind.
Mchenry, IL, US
Received
July 13, 1981
Decision date
July 27, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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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
K833496Oxygen Monitor/ControllerCCL · Traditional 12/16/1983SE
K812624Oxequip Conductive & Non Anes. BreathCAI · Traditional 10/26/1981SE
K800369Tri Pac Mouth PropJXL · Traditional 02/28/1980SE
K792356Oxequip Model 34 Med*Star Oxygen MonitorCCL · Traditional 12/04/1979SE

Questions and answers

When was Oxy-Quik Mark IV Oxygen Inhalator cleared by the FDA?

Oxy-Quik Mark IV Oxygen Inhalator (K811987) received a 510(k) decision of Substantially Equivalent on July 27, 1981, 14 days after the submission was received.

What is the product code of K811987?

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