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FDA 510(k)

CARDIO PERFECT ST 2001

K-Number: K935732 · 1996-04-04

ApplicantCardio Control BV
Decision Date1996-04-04
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO PERFECT ST 2001 is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Control BV. It received FDA 510(k) clearance on 1996-04-04 under 510(k) number K935732. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO PERFECT ST 2001?

CARDIO PERFECT ST 2001 is a medical device that received FDA 510(k) clearance on 1996-04-04. The listed applicant is Cardio Control BV. The 510(k) number is K935732.

When did CARDIO PERFECT ST 2001 receive FDA 510(k) clearance?

CARDIO PERFECT ST 2001 received FDA 510(k) clearance on 1996-04-04, under 510(k) number K935732.

Who is the listed applicant for CARDIO PERFECT ST 2001?

The FDA 510(k) record lists Cardio Control BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO PERFECT ST 2001?

The FDA product code for CARDIO PERFECT ST 2001 is DSI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Cardio Control BV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K962854HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECTK922898CARDIO PERFECT, CARDIO PERFECT MDK913374CARDIO PERFECT, CARDIO PERFECT MD

Related Devices (Code: DSI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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