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FDA 510(k)

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

K-Number: K201983 · 2020-10-09

Decision Date2020-10-09
Product CodePFO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) is a medical device manufactured by Med-El Elektromedizinische Geraete GmbH. It received FDA 510(k) clearance on 2020-10-09 under approval number K201983. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)?

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) is a medical device that received FDA 510(k) clearance on 2020-10-09. It is manufactured by Med-El Elektromedizinische Geraete GmbH. The 510(k) number is K201983.

When was BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) approved by the FDA?

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) received FDA 510(k) clearance on 2020-10-09, under approval number K201983.

What company makes BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)?

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) is manufactured by Med-El Elektromedizinische Geraete GmbH.

What is the FDA product code for BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)?

The FDA product code for BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) is PFO.

Other Devices by Med-El Elektromedizinische Geraete GmbH

Related Devices (Code: PFO)

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.