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FDA 510(k)

Signus Tetris™ St; Signus Tetris™ R St

K-Number: K241438 · 2024-09-11

ApplicantSignus Medizintechnik GmbH
Decision Date2024-09-11
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Signus Tetris™ St; Signus Tetris™ R St is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2024-09-11 under 510(k) number K241438. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Signus Tetris™ St; Signus Tetris™ R St?

Signus Tetris™ St; Signus Tetris™ R St is a medical device that received FDA 510(k) clearance on 2024-09-11. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K241438.

When did Signus Tetris™ St; Signus Tetris™ R St receive FDA 510(k) clearance?

Signus Tetris™ St; Signus Tetris™ R St received FDA 510(k) clearance on 2024-09-11, under 510(k) number K241438.

Who is the listed applicant for Signus Tetris™ St; Signus Tetris™ R St?

The FDA 510(k) record lists Signus Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signus Tetris™ St; Signus Tetris™ R St?

The FDA product code for Signus Tetris™ St; Signus Tetris™ R St is MAX.

Other records listing Signus Medizintechnik GmbH 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.

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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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