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FDA 510(k)

CARDIO-CARD MANAGEMENT SYSTEM II

K-Number: K972795 · 1998-02-20

ApplicantNasiff Assoc., Inc.
Decision Date1998-02-20
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO-CARD MANAGEMENT SYSTEM II 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 1998-02-20 under 510(k) number K972795. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO-CARD MANAGEMENT SYSTEM II?

CARDIO-CARD MANAGEMENT SYSTEM II is a medical device that received FDA 510(k) clearance on 1998-02-20. The listed applicant is Nasiff Assoc., Inc.. The 510(k) number is K972795.

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

CARDIO-CARD MANAGEMENT SYSTEM II received FDA 510(k) clearance on 1998-02-20, under 510(k) number K972795.

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

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 MANAGEMENT SYSTEM II?

The FDA product code for CARDIO-CARD MANAGEMENT SYSTEM II is DXN.

Related Clinical Trials

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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 IK960544CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEMK920020CARDIO-CARD ECG MANAGEMENT SYSTEMK903722MICROMED QRS CARD

Related Devices (Code: DXN)

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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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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