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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 the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2020-03-17 under 510(k) 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. The listed applicant is Bisco, Inc.. The 510(k) number is K192007.

When did TheraBase, TheraBase Ca receive FDA 510(k) clearance?

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

Who is the listed applicant for TheraBase, TheraBase Ca?

The FDA 510(k) record lists Bisco, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Bisco, Inc. as applicant

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Related Devices (Code: 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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