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FDA 510(k)

EXACTA-SPEZIAL

K-Number: K925295 · 1994-03-25

ApplicantRudolf Riester GmbH & Co. KG
Decision Date1994-03-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXACTA-SPEZIAL 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 1994-03-25 under 510(k) number K925295. 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 EXACTA-SPEZIAL?

EXACTA-SPEZIAL is a medical device that received FDA 510(k) clearance on 1994-03-25. The listed applicant is Rudolf Riester GmbH & Co. KG. The 510(k) number is K925295.

When did EXACTA-SPEZIAL receive FDA 510(k) clearance?

EXACTA-SPEZIAL received FDA 510(k) clearance on 1994-03-25, under 510(k) number K925295.

Who is the listed applicant for EXACTA-SPEZIAL?

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 EXACTA-SPEZIAL?

The FDA product code for EXACTA-SPEZIAL is DXN.

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Other records listing Rudolf Riester GmbH & Co. KG as applicant

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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

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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