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FDA 510(k)

E-STATIS 40 SYSTEM

K-Number: K090937 · 2009-07-24

ApplicantScican , Ltd.
Decision Date2009-07-24
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

E-STATIS 40 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Scican , Ltd.. It received FDA 510(k) clearance on 2009-07-24 under 510(k) number K090937. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-STATIS 40 SYSTEM?

E-STATIS 40 SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Scican , Ltd.. The 510(k) number is K090937.

When did E-STATIS 40 SYSTEM receive FDA 510(k) clearance?

E-STATIS 40 SYSTEM received FDA 510(k) clearance on 2009-07-24, under 510(k) number K090937.

Who is the listed applicant for E-STATIS 40 SYSTEM?

The FDA 510(k) record lists Scican , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-STATIS 40 SYSTEM?

The FDA product code for E-STATIS 40 SYSTEM is EBW.

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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.

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