EM Provisional
K-Number: K191751 · 2019-12-16
ApplicantHiossen, Inc.
Decision Date2019-12-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EM Provisional is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2019-12-16 under approval number K191751. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EM Provisional?
EM Provisional is a medical device that received FDA 510(k) clearance on 2019-12-16. It is manufactured by Hiossen, Inc.. The 510(k) number is K191751.
When was EM Provisional approved by the FDA?
EM Provisional received FDA 510(k) clearance on 2019-12-16, under approval number K191751.
What company makes EM Provisional?
EM Provisional is manufactured by Hiossen, Inc..
What is the FDA product code for EM Provisional?
The FDA product code for EM Provisional is DZE.
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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.