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FDA 510(k)

CARDIO-CARD ECG MANAGEMENT SYSTEM

K-Number: K920020 · 1992-07-09

ApplicantNasiff Assoc., Inc.
Decision Date1992-07-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO-CARD ECG MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nasiff Assoc., Inc.. It received FDA 510(k) clearance on 1992-07-09 under 510(k) number K920020. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO-CARD ECG MANAGEMENT SYSTEM?

CARDIO-CARD ECG MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1992-07-09. The listed applicant is Nasiff Assoc., Inc.. The 510(k) number is K920020.

When did CARDIO-CARD ECG MANAGEMENT SYSTEM receive FDA 510(k) clearance?

CARDIO-CARD ECG MANAGEMENT SYSTEM received FDA 510(k) clearance on 1992-07-09, under 510(k) number K920020.

Who is the listed applicant for CARDIO-CARD ECG MANAGEMENT SYSTEM?

The FDA 510(k) record lists Nasiff Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIO-CARD ECG MANAGEMENT SYSTEM?

The FDA product code for CARDIO-CARD ECG MANAGEMENT SYSTEM is DPS.

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 Nasiff Assoc., Inc. 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.

K993616CARDIO-CARD INTERPRETATION SYSTEM IK972795CARDIO-CARD MANAGEMENT SYSTEM IIK960544CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEMK903722MICROMED QRS CARD

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

Official Source

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

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