Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CARDIO PERFECT, CARDIO PERFECT MD

K-Number: K922898 · 1993-11-01

ApplicantCardio Control BV
Decision Date1993-11-01
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDIO PERFECT, CARDIO PERFECT MD 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 1993-11-01 under 510(k) number K922898. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO PERFECT, CARDIO PERFECT MD?

CARDIO PERFECT, CARDIO PERFECT MD is a medical device that received FDA 510(k) clearance on 1993-11-01. The listed applicant is Cardio Control BV. The 510(k) number is K922898.

When did CARDIO PERFECT, CARDIO PERFECT MD receive FDA 510(k) clearance?

CARDIO PERFECT, CARDIO PERFECT MD received FDA 510(k) clearance on 1993-11-01, under 510(k) number K922898.

Who is the listed applicant for CARDIO PERFECT, CARDIO PERFECT MD?

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, CARDIO PERFECT MD?

The FDA product code for CARDIO PERFECT, CARDIO PERFECT MD 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.

K962854HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFTWARE:CARDIO PERFECT (V. 4.0 AND UP FOR DOS), CARDIO PERFECTK935732CARDIO PERFECT ST 2001K913374CARDIO 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.

↑