Ultra-Chek Pacemaker Monitor

FDA 510(k) K801022 · Powers Medical Systmes

Substantially Equivalent

510(k) numberK801022

Submission

Device name
Ultra-Chek Pacemaker Monitor
Applicant
Powers Medical Systmes
Walker, MI, US
Received
April 30, 1980
Decision date
June 17, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KRE – Analyzer, Pacemaker Generator Function, Indirect
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3640
Specialty
Cardiovascular

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K110693Paceart Optima System SoftwareKRE · Traditional Medtronic, Inc.06/08/2011SE
K072950Cygnus 12 Lead ECG ModuleKRE · Traditional Cygnus, LLC08/22/2008SE
K032926EKG SpeaksKRE · Special Medtronic Vascular10/15/2003SE
K922742HPM 40 Heart Pacemaker MonitorKRE · Traditional Biotronik, GmbH & Co.03/18/1993SE
K915632Paceart CPTS-86/12KRE · Traditional Paceart, Inc.04/14/1992SE
K895535PaceviewKRE · Traditional Micromedical03/19/1990SE
K870909Pacemaker Function AnalyzerKRE · Traditional Paceart, Inc.04/27/1987SE
K833647Pacemaker Sys Analyzer #384KRE · Traditional Pacesetter Systems12/16/1983SE
K832959Pacemaker Sys. Analyzer 378KRE · Traditional Siemens Elema AB11/14/1983SE
K803286CardiomemoKRE · Traditional Instromedix, Inc.03/17/1981SE

More from Instromedix, Inc.

510(k)DeviceDecision
K811758Accu-Chek Trans-Telephonic Pacemaker TRDXH · Traditional 08/03/1981SE
K802779Load Sentinel II, Trans. Elec. NerveGZJ · Traditional 12/10/1980SE

Questions and answers

When was Ultra-Chek Pacemaker Monitor cleared by the FDA?

Ultra-Chek Pacemaker Monitor (K801022) received a 510(k) decision of Substantially Equivalent on June 17, 1980, 48 days after the submission was received.

What is the product code of K801022?

The FDA product code is KRE – Analyzer, Pacemaker Generator Function, Indirect, a Class II (moderate risk) device regulated under 21 CFR 870.3640.