BlastGen
K-Number: K152932 · 2016-02-29
ApplicantOrigio A/S
Decision Date2016-02-29
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
BlastGen is a medical device manufactured by Origio A/S. It received FDA 510(k) clearance on 2016-02-29 under approval number K152932. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BlastGen?
BlastGen is a medical device that received FDA 510(k) clearance on 2016-02-29. It is manufactured by Origio A/S. The 510(k) number is K152932.
When was BlastGen approved by the FDA?
BlastGen received FDA 510(k) clearance on 2016-02-29, under approval number K152932.
What company makes BlastGen?
BlastGen is manufactured by Origio A/S.
What is the FDA product code for BlastGen?
The FDA product code for BlastGen is MQL.
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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.