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FDA 510(k)

Avicenna Roboflex

K-Number: K233700 · 2024-08-16

ApplicantElmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi
Decision Date2024-08-16
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Avicenna Roboflex is the device name listed in this FDA 510(k) record. The listed applicant is Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2024-08-16 under 510(k) number K233700. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avicenna Roboflex?

Avicenna Roboflex is a medical device that received FDA 510(k) clearance on 2024-08-16. The listed applicant is Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi. The 510(k) number is K233700.

When did Avicenna Roboflex receive FDA 510(k) clearance?

Avicenna Roboflex received FDA 510(k) clearance on 2024-08-16, under 510(k) number K233700.

Who is the listed applicant for Avicenna Roboflex?

The FDA 510(k) record lists Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avicenna Roboflex?

The FDA product code for Avicenna Roboflex is FGB.

Related Devices (Code: FGB)

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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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