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FDA 510(k)

STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101

K-Number: K072466 · 2007-12-19

ApplicantScican , Ltd.
Decision Date2007-12-19
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 is the device name listed in this FDA 510(k) record. The listed applicant is Scican , Ltd.. It received FDA 510(k) clearance on 2007-12-19 under 510(k) number K072466. 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 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101?

STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 is a medical device that received FDA 510(k) clearance on 2007-12-19. The listed applicant is Scican , Ltd.. The 510(k) number is K072466.

When did STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 receive FDA 510(k) clearance?

STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 received FDA 510(k) clearance on 2007-12-19, under 510(k) number K072466.

Who is the listed applicant for STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101?

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 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101?

The FDA product code for STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101 is FLE.

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Related Devices (Code: FLE)

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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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