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FDA 510(k)

TheraBase, TheraBase Ca

K-Number: K192007 · 2020-03-17

ApplicantBisco, Inc.
Decision Date2020-03-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TheraBase, TheraBase Ca is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2020-03-17 under approval number K192007. 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 TheraBase, TheraBase Ca?

TheraBase, TheraBase Ca is a medical device that received FDA 510(k) clearance on 2020-03-17. It is manufactured by Bisco, Inc.. The 510(k) number is K192007.

When was TheraBase, TheraBase Ca approved by the FDA?

TheraBase, TheraBase Ca received FDA 510(k) clearance on 2020-03-17, under approval number K192007.

What company makes TheraBase, TheraBase Ca?

TheraBase, TheraBase Ca is manufactured by Bisco, Inc..

What is the FDA product code for TheraBase, TheraBase Ca?

The FDA product code for TheraBase, TheraBase Ca is EMA.

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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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