TheraCal DC
K-Number: K180344 · 2018-04-05
ApplicantBisco, Inc.
Decision Date2018-04-05
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TheraCal DC is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2018-04-05 under approval number K180344. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TheraCal DC?
TheraCal DC is a medical device that received FDA 510(k) clearance on 2018-04-05. It is manufactured by Bisco, Inc.. The 510(k) number is K180344.
When was TheraCal DC approved by the FDA?
TheraCal DC received FDA 510(k) clearance on 2018-04-05, under approval number K180344.
What company makes TheraCal DC?
TheraCal DC is manufactured by Bisco, Inc..
What is the FDA product code for TheraCal DC?
The FDA product code for TheraCal DC is EJK.
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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.