TheraCem
K-Number: K161256 · 2016-07-29
ApplicantBisco, Inc.
Decision Date2016-07-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TheraCem is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2016-07-29 under approval number K161256. 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 TheraCem?
TheraCem is a medical device that received FDA 510(k) clearance on 2016-07-29. It is manufactured by Bisco, Inc.. The 510(k) number is K161256.
When was TheraCem approved by the FDA?
TheraCem received FDA 510(k) clearance on 2016-07-29, under approval number K161256.
What company makes TheraCem?
TheraCem is manufactured by Bisco, Inc..
What is the FDA product code for TheraCem?
The FDA product code for TheraCem 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.