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FDA 510(k)

BIG BEN SQUARE, BIG BEN ROUND

K-Number: K972301 · 1997-09-17

ApplicantRudolf Riester GmbH & Co. KG
Decision Date1997-09-17
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIG BEN SQUARE, BIG BEN ROUND 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 1997-09-17 under 510(k) number K972301. 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 BIG BEN SQUARE, BIG BEN ROUND?

BIG BEN SQUARE, BIG BEN ROUND is a medical device that received FDA 510(k) clearance on 1997-09-17. The listed applicant is Rudolf Riester GmbH & Co. KG. The 510(k) number is K972301.

When did BIG BEN SQUARE, BIG BEN ROUND receive FDA 510(k) clearance?

BIG BEN SQUARE, BIG BEN ROUND received FDA 510(k) clearance on 1997-09-17, under 510(k) number K972301.

Who is the listed applicant for BIG BEN SQUARE, BIG BEN ROUND?

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 BIG BEN SQUARE, BIG BEN ROUND?

The FDA product code for BIG BEN SQUARE, BIG BEN ROUND is DXQ.

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

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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.

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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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