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FDA 510(k)

IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT

K-Number: K113279 · 2011-11-14

ApplicantKettenbach GmbH & Co. KG
Decision Date2011-11-14
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2011-11-14 under 510(k) number K113279. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT?

IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT is a medical device that received FDA 510(k) clearance on 2011-11-14. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K113279.

When did IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT receive FDA 510(k) clearance?

IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT received FDA 510(k) clearance on 2011-11-14, under 510(k) number K113279.

Who is the listed applicant for IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT?

The FDA 510(k) record lists Kettenbach GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT?

The FDA product code for IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT is ELW.

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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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