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FDA 510(k)

PRECISA N

K-Number: K972379 · 1997-09-24

Decision Date1997-09-24
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRECISA N is the device name listed in this FDA 510(k) record. The listed applicant is Rudolf Riester GmbH & Co. KG. It received FDA 510(k) clearance on 1997-09-24 under 510(k) number K972379. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISA N?

PRECISA N is a medical device that received FDA 510(k) clearance on 1997-09-24. The listed applicant is Rudolf Riester GmbH & Co. KG. The 510(k) number is K972379.

When did PRECISA N receive FDA 510(k) clearance?

PRECISA N received FDA 510(k) clearance on 1997-09-24, under 510(k) number K972379.

Who is the listed applicant for PRECISA N?

The FDA 510(k) record lists Rudolf Riester GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECISA N?

The FDA product code for PRECISA N is DXQ.

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.

Other records listing Rudolf Riester GmbH & Co. KG 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.

View all 30 devices →

Related Devices (Code: DXQ)

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.

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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