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FDA 510(k)

Bellavista

K-Number: K183364 · 2019-09-13

ApplicantImtmedical AG
Decision Date2019-09-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Bellavista is a medical device manufactured by Imtmedical AG. It received FDA 510(k) clearance on 2019-09-13 under approval number K183364. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bellavista?

Bellavista is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Imtmedical AG. The 510(k) number is K183364.

When was Bellavista approved by the FDA?

Bellavista received FDA 510(k) clearance on 2019-09-13, under approval number K183364.

What company makes Bellavista?

Bellavista is manufactured by Imtmedical AG.

What is the FDA product code for Bellavista?

The FDA product code for Bellavista is CBK.

Other Devices by Imtmedical AG

Related Devices (Code: CBK)

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.