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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biopsybell S.R.L.. It received FDA 510(k) clearance on 2018-03-26 under 510(k) 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. The listed applicant is Biopsybell S.R.L.. The 510(k) number is K180315.

When did DISKOM receive FDA 510(k) clearance?

DISKOM received FDA 510(k) clearance on 2018-03-26, under 510(k) number K180315.

Who is the listed applicant for DISKOM?

The FDA 510(k) record lists Biopsybell S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISKOM?

The FDA product code for DISKOM is HRX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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