DISKOM
K-Number: K180315 · 2018-03-26
ApplicantBiopsybell S.R.L.
Decision Date2018-03-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
DISKOM is a medical device manufactured by Biopsybell S.R.L.. It received FDA 510(k) clearance on 2018-03-26 under approval number K180315. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DISKOM?
DISKOM is a medical device that received FDA 510(k) clearance on 2018-03-26. It is manufactured by Biopsybell S.R.L.. The 510(k) number is K180315.
When was DISKOM approved by the FDA?
DISKOM received FDA 510(k) clearance on 2018-03-26, under approval number K180315.
What company makes DISKOM?
DISKOM is manufactured by Biopsybell S.R.L..
What is the FDA product code for DISKOM?
The FDA product code for DISKOM is HRX.
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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.