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FDA 510(k)

Calprest, EasyCal

K-Number: K191589 · 2019-07-10

ApplicantEurospital S.P.A.
Decision Date2019-07-10
Product CodeNXO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Calprest, EasyCal 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 2019-07-10 under 510(k) number K191589. 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, EasyCal?

Calprest, EasyCal is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Eurospital S.P.A.. The 510(k) number is K191589.

When did Calprest, EasyCal receive FDA 510(k) clearance?

Calprest, EasyCal received FDA 510(k) clearance on 2019-07-10, under 510(k) number K191589.

Who is the listed applicant for Calprest, EasyCal?

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, EasyCal?

The FDA product code for Calprest, EasyCal 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, EasyCalK160447Calprest NG

Related Devices (Code: NXO)

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.

K232057BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AGK220763ALPCO Calprotectin Immunoturbidimetric AssayALPCOK213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCOK191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AGK191592CalprestNG, 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.

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