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FDA 510(k)

NON-STETHO 7, UM-15TP

K-Number: K821989 · 1982-10-18

ApplicantHirata Sangyo Co. USA, Inc.
Decision Date1982-10-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NON-STETHO 7, UM-15TP is the device name listed in this FDA 510(k) record. The listed applicant is Hirata Sangyo Co. USA, Inc.. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K821989. 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 NON-STETHO 7, UM-15TP?

NON-STETHO 7, UM-15TP is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Hirata Sangyo Co. USA, Inc.. The 510(k) number is K821989.

When did NON-STETHO 7, UM-15TP receive FDA 510(k) clearance?

NON-STETHO 7, UM-15TP received FDA 510(k) clearance on 1982-10-18, under 510(k) number K821989.

Who is the listed applicant for NON-STETHO 7, UM-15TP?

The FDA 510(k) record lists Hirata Sangyo Co. USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-STETHO 7, UM-15TP?

The FDA product code for NON-STETHO 7, UM-15TP is DXN.

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Other records listing Hirata Sangyo Co. USA, Inc. as applicant

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Related Devices (Code: DXN)

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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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