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FDA 510(k)

FBC 921 (ALIF)

K-Number: K180695 · 2018-07-12

ApplicantFbc Device Aps
Decision Date2018-07-12
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FBC 921 (ALIF) is a medical device manufactured by Fbc Device Aps. It received FDA 510(k) clearance on 2018-07-12 under approval number K180695. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FBC 921 (ALIF)?

FBC 921 (ALIF) is a medical device that received FDA 510(k) clearance on 2018-07-12. It is manufactured by Fbc Device Aps. The 510(k) number is K180695.

When was FBC 921 (ALIF) approved by the FDA?

FBC 921 (ALIF) received FDA 510(k) clearance on 2018-07-12, under approval number K180695.

What company makes FBC 921 (ALIF)?

FBC 921 (ALIF) is manufactured by Fbc Device Aps.

What is the FDA product code for FBC 921 (ALIF)?

The FDA product code for FBC 921 (ALIF) is OVD.

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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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