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FDA 510(k)

NBP 488, TPR 488

K-Number: K861856 · 1986-12-22

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1986-12-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NBP 488, TPR 488 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K861856. 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 NBP 488, TPR 488?

NBP 488, TPR 488 is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K861856.

When did NBP 488, TPR 488 receive FDA 510(k) clearance?

NBP 488, TPR 488 received FDA 510(k) clearance on 1986-12-22, under 510(k) number K861856.

Who is the listed applicant for NBP 488, TPR 488?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NBP 488, TPR 488?

The FDA product code for NBP 488, TPR 488 is 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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