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FDA 510(k)

SPHYGMOMANOMETER

K-Number: K812409 · 1981-11-02

ApplicantSomatronix Research Corp.
Decision Date1981-11-02
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPHYGMOMANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Somatronix Research Corp.. It received FDA 510(k) clearance on 1981-11-02 under 510(k) number K812409. 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 SPHYGMOMANOMETER?

SPHYGMOMANOMETER is a medical device that received FDA 510(k) clearance on 1981-11-02. The listed applicant is Somatronix Research Corp.. The 510(k) number is K812409.

When did SPHYGMOMANOMETER receive FDA 510(k) clearance?

SPHYGMOMANOMETER received FDA 510(k) clearance on 1981-11-02, under 510(k) number K812409.

Who is the listed applicant for SPHYGMOMANOMETER?

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

What is the FDA product code for SPHYGMOMANOMETER?

The FDA product code for SPHYGMOMANOMETER is DXN.

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.

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Other records listing Somatronix Research Corp. 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.

K832421BATTERY-OPERATED ELECTROCARDIOGRAPH

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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