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FDA 510(k)

WINNER SELF-TAKING HOME BLOOD PRESSURE KIT

K-Number: K942163 · 1994-12-20

ApplicantWinmed Instruments Mfg. Corp.
Decision Date1994-12-20
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WINNER SELF-TAKING HOME BLOOD PRESSURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Winmed Instruments Mfg. Corp.. It received FDA 510(k) clearance on 1994-12-20 under 510(k) number K942163. 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 WINNER SELF-TAKING HOME BLOOD PRESSURE KIT?

WINNER SELF-TAKING HOME BLOOD PRESSURE KIT is a medical device that received FDA 510(k) clearance on 1994-12-20. The listed applicant is Winmed Instruments Mfg. Corp.. The 510(k) number is K942163.

When did WINNER SELF-TAKING HOME BLOOD PRESSURE KIT receive FDA 510(k) clearance?

WINNER SELF-TAKING HOME BLOOD PRESSURE KIT received FDA 510(k) clearance on 1994-12-20, under 510(k) number K942163.

Who is the listed applicant for WINNER SELF-TAKING HOME BLOOD PRESSURE KIT?

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

What is the FDA product code for WINNER SELF-TAKING HOME BLOOD PRESSURE KIT?

The FDA product code for WINNER SELF-TAKING HOME BLOOD PRESSURE KIT is DXN.

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Other records listing Winmed Instruments Mfg. Corp. 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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