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FDA 510(k)

Elite SPK, Compasso, Elite SPK Kit

K-Number: K160500 · 2016-04-20

ApplicantNcs Lab Srl
Decision Date2016-04-20
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Elite SPK, Compasso, Elite SPK Kit is the device name listed in this FDA 510(k) record. The listed applicant is Ncs Lab Srl. It received FDA 510(k) clearance on 2016-04-20 under 510(k) number K160500. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elite SPK, Compasso, Elite SPK Kit?

Elite SPK, Compasso, Elite SPK Kit is a medical device that received FDA 510(k) clearance on 2016-04-20. The listed applicant is Ncs Lab Srl. The 510(k) number is K160500.

When did Elite SPK, Compasso, Elite SPK Kit receive FDA 510(k) clearance?

Elite SPK, Compasso, Elite SPK Kit received FDA 510(k) clearance on 2016-04-20, under 510(k) number K160500.

Who is the listed applicant for Elite SPK, Compasso, Elite SPK Kit?

The FDA 510(k) record lists Ncs Lab Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elite SPK, Compasso, Elite SPK Kit?

The FDA product code for Elite SPK, Compasso, Elite SPK Kit is MBI.

Other records listing Ncs Lab Srl as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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