FDA 510(k)

Calprest NG

K-Number: K160447 · 2016-11-10

Decision Date2016-11-10

Product CodeNXO

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Calprest NG is the device name listed in this FDA 510(k) record. The listed applicant is Eurospital S.P.A.. It received FDA 510(k) clearance on 2016-11-10 under 510(k) number K160447. The device is classified under product code NXO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Calprest NG?

Calprest NG is a medical device that received FDA 510(k) clearance on 2016-11-10. The listed applicant is Eurospital S.P.A.. The 510(k) number is K160447.

When did Calprest NG receive FDA 510(k) clearance?

Calprest NG received FDA 510(k) clearance on 2016-11-10, under 510(k) number K160447.

Who is the listed applicant for Calprest NG?

The FDA 510(k) record lists Eurospital S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Calprest NG?

The FDA product code for Calprest NG is NXO.

Other records listing Eurospital S.P.A. 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.

K191592CalprestNG, EasyCal K191589Calprest, EasyCal

Related Devices (Code: NXO)

K232057BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG K220763ALPCO Calprotectin Immunoturbidimetric AssayALPCO K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCO K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG K191592CalprestNG, EasyCalEurospital S.P.A.

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.