Cardio Perfect ST 2001

FDA 510(k) K935732 · Cardio Control BV

Substantially Equivalent

510(k) numberK935732

Submission

Device name
Cardio Perfect ST 2001
Applicant
Cardio Control BV
The Netherlands, NL
Received
December 1, 1993
Decision date
April 4, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DSI – Detector And Alarm, Arrhythmia
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1025
Specialty
Cardiovascular

Other 510(k)s with product code DSI

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K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional Boston Scientific Cardiac Diagnostic…01/23/2026SE
K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional Infobionic, Inc.07/29/2025SE
K240177Zio AT® device (A100A1001)DSI · Traditional iRhythm Technologies, Inc.10/30/2024SE
K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated Infobionic, Inc.10/06/2023SE
K231276SmartCardia 7L PlatformDSI · Traditional Smartcardia SA08/30/2023SE
K193104Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special Medicalgorithmics S.A.04/09/2020SE
K192732BodyGuardian Remote Monitoring SystemDSI · Traditional Preventice Technologies, Inc.03/26/2020SE
K190574Patient Assistant Model PA97000DSI · Traditional Medtronic, Inc.09/24/2019SE
K182532Liba3 SystemDSI · Traditional National Cardiac, Inc.05/15/2019SE
K181658MobileECG 2 BTDSI · Traditional Memtec Corporation03/26/2019SE

More from Memtec Corporation

510(k)DeviceDecision
K962854Hardware:Cardio Perfect Portable, Cardio Perfect MD and Software:Cardio Perfect (V. 4.0…LOS · Traditional 01/27/1997SE
K922898Cardio Perfect, Cardio Perfect MDLOS · Traditional 11/01/1993SE
K913374Cardio Perfect, Cardio Perfect MDDPS · Traditional 01/23/1992SE

Questions and answers

When was Cardio Perfect ST 2001 cleared by the FDA?

Cardio Perfect ST 2001 (K935732) received a 510(k) decision of Substantially Equivalent on April 4, 1996, 855 days after the submission was received.

What is the product code of K935732?

The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.