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FDA 510(k)

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

K-Number: K962854 · 1997-01-27

ApplicantCardio Control BV
Decision Date1997-01-27
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT 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 1997-01-27 under 510(k) number K962854. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT?

HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT is a medical device that received FDA 510(k) clearance on 1997-01-27. The listed applicant is Cardio Control BV. The 510(k) number is K962854.

When did HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT receive FDA 510(k) clearance?

HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT received FDA 510(k) clearance on 1997-01-27, under 510(k) number K962854.

Who is the listed applicant for HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT?

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 HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT?

The FDA product code for HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECT is LOS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K935732CARDIO PERFECT ST 2001K922898CARDIO PERFECT, CARDIO PERFECT MDK913374CARDIO PERFECT, CARDIO PERFECT MD

Related Devices (Code: LOS)

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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., Inc.

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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