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FDA 510(k)

FLEXITIME MONOPHASE PRO SCAN

K-Number: K113574 · 2012-07-13

ApplicantHeraeus Kulzer, LLC
Decision Date2012-07-13
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXITIME MONOPHASE PRO SCAN 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 2012-07-13 under 510(k) number K113574. 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 MONOPHASE PRO SCAN?

FLEXITIME MONOPHASE PRO SCAN is a medical device that received FDA 510(k) clearance on 2012-07-13. The listed applicant is Heraeus Kulzer, LLC. The 510(k) number is K113574.

When did FLEXITIME MONOPHASE PRO SCAN receive FDA 510(k) clearance?

FLEXITIME MONOPHASE PRO SCAN received FDA 510(k) clearance on 2012-07-13, under 510(k) number K113574.

Who is the listed applicant for FLEXITIME MONOPHASE PRO SCAN?

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 MONOPHASE PRO SCAN?

The FDA product code for FLEXITIME MONOPHASE PRO SCAN is ELW.

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Related Devices (Code: 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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