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FDA 510(k)

Choice 2 DC

K-Number: K250156 · 2025-07-11

ApplicantBisco, Inc.
Decision Date2025-07-11
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Choice 2 DC is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2025-07-11 under approval number K250156. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Choice 2 DC?

Choice 2 DC is a medical device that received FDA 510(k) clearance on 2025-07-11. It is manufactured by Bisco, Inc.. The 510(k) number is K250156.

When was Choice 2 DC approved by the FDA?

Choice 2 DC received FDA 510(k) clearance on 2025-07-11, under approval number K250156.

What company makes Choice 2 DC?

Choice 2 DC is manufactured by Bisco, Inc..

What is the FDA product code for Choice 2 DC?

The FDA product code for Choice 2 DC is EMA.

Other Devices by Bisco, Inc.

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Related Devices (Code: EMA)

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.