FDA 510(k)

FLEXITIME FAST & SCAN LIGHT FLOW

K-Number: K120914 · 2012-07-25

Decision Date2012-07-25

Product CodeELW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

FLEXITIME FAST & SCAN LIGHT FLOW is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, LLC. It received FDA 510(k) clearance on 2012-07-25 under 510(k) number K120914. 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 FLEXITIME FAST & SCAN LIGHT FLOW?

FLEXITIME FAST & SCAN LIGHT FLOW is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is Heraeus Kulzer, LLC. The 510(k) number is K120914.

When did FLEXITIME FAST & SCAN LIGHT FLOW receive FDA 510(k) clearance?

FLEXITIME FAST & SCAN LIGHT FLOW received FDA 510(k) clearance on 2012-07-25, under 510(k) number K120914.

Who is the listed applicant for FLEXITIME FAST & SCAN LIGHT FLOW?

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

What is the FDA product code for FLEXITIME FAST & SCAN LIGHT FLOW?

The FDA product code for FLEXITIME FAST & SCAN LIGHT FLOW is ELW.

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Other records listing Heraeus Kulzer, LLC as applicant

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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.