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FDA 510(k)

HOME BLOOD PRESSURE KIT, ANEROID

K-Number: K884420 · 1989-08-25

ApplicantYamasu Co. , Ltd.
Decision Date1989-08-25
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOME BLOOD PRESSURE KIT, ANEROID is the device name listed in this FDA 510(k) record. The listed applicant is Yamasu Co. , Ltd.. It received FDA 510(k) clearance on 1989-08-25 under 510(k) number K884420. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOME BLOOD PRESSURE KIT, ANEROID?

HOME BLOOD PRESSURE KIT, ANEROID is a medical device that received FDA 510(k) clearance on 1989-08-25. The listed applicant is Yamasu Co. , Ltd.. The 510(k) number is K884420.

When did HOME BLOOD PRESSURE KIT, ANEROID receive FDA 510(k) clearance?

HOME BLOOD PRESSURE KIT, ANEROID received FDA 510(k) clearance on 1989-08-25, under 510(k) number K884420.

Who is the listed applicant for HOME BLOOD PRESSURE KIT, ANEROID?

The FDA 510(k) record lists Yamasu Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOME BLOOD PRESSURE KIT, ANEROID?

The FDA product code for HOME BLOOD PRESSURE KIT, ANEROID is DXY. This falls under the Clinical Chemistry category.

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 Yamasu Co. , Ltd. 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.

K901506ANEROID SPHYGMOMANOMETER, DOCTOR TYPE

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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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