FDA 510(k)

STATIM 2000 G4 CASSETTE

K-Number: K112872 · 2012-07-10

Decision Date2012-07-10

Product CodeFLE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STATIM 2000 G4 CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Scican , Ltd.. It received FDA 510(k) clearance on 2012-07-10 under 510(k) number K112872. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATIM 2000 G4 CASSETTE?

STATIM 2000 G4 CASSETTE is a medical device that received FDA 510(k) clearance on 2012-07-10. The listed applicant is Scican , Ltd.. The 510(k) number is K112872.

When did STATIM 2000 G4 CASSETTE receive FDA 510(k) clearance?

STATIM 2000 G4 CASSETTE received FDA 510(k) clearance on 2012-07-10, under 510(k) number K112872.

Who is the listed applicant for STATIM 2000 G4 CASSETTE?

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 STATIM 2000 G4 CASSETTE?

The FDA product code for STATIM 2000 G4 CASSETTE is FLE.

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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.