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FDA 510(k)

CARDTEL, MODEL NT-100

K-Number: K000609 · 2000-05-23

ApplicantCardiac Telecommunications
Decision Date2000-05-23
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDTEL, MODEL NT-100 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Telecommunications. It received FDA 510(k) clearance on 2000-05-23 under 510(k) number K000609. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDTEL, MODEL NT-100?

CARDTEL, MODEL NT-100 is a medical device that received FDA 510(k) clearance on 2000-05-23. The listed applicant is Cardiac Telecommunications. The 510(k) number is K000609.

When did CARDTEL, MODEL NT-100 receive FDA 510(k) clearance?

CARDTEL, MODEL NT-100 received FDA 510(k) clearance on 2000-05-23, under 510(k) number K000609.

Who is the listed applicant for CARDTEL, MODEL NT-100?

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

What is the FDA product code for CARDTEL, MODEL NT-100?

The FDA product code for CARDTEL, MODEL NT-100 is MWJ.

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Related Devices (Code: MWJ)

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

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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