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FDA 510(k)

CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER

K-Number: K942546 · 1995-01-27

ApplicantDynatech/Nevada, Inc.
Decision Date1995-01-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech/Nevada, Inc.. It received FDA 510(k) clearance on 1995-01-27 under 510(k) number K942546. 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 CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER?

CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Dynatech/Nevada, Inc.. The 510(k) number is K942546.

When did CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER receive FDA 510(k) clearance?

CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER received FDA 510(k) clearance on 1995-01-27, under 510(k) number K942546.

Who is the listed applicant for CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER?

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

What is the FDA product code for CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER?

The FDA product code for CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER is DXN.

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Other records listing Dynatech/Nevada, Inc. as applicant

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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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