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FDA 510(k)

HEADFIX

K-Number: K030439 · 2003-05-08

ApplicantMedical Intelligence Medizintechnik GmbH
Decision Date2003-05-08
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEADFIX is the device name listed in this FDA 510(k) record. The listed applicant is Medical Intelligence Medizintechnik GmbH. It received FDA 510(k) clearance on 2003-05-08 under 510(k) number K030439. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEADFIX?

HEADFIX is a medical device that received FDA 510(k) clearance on 2003-05-08. The listed applicant is Medical Intelligence Medizintechnik GmbH. The 510(k) number is K030439.

When did HEADFIX receive FDA 510(k) clearance?

HEADFIX received FDA 510(k) clearance on 2003-05-08, under 510(k) number K030439.

Who is the listed applicant for HEADFIX?

The FDA 510(k) record lists Medical Intelligence Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEADFIX?

The FDA product code for HEADFIX is IYE.

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Other records listing Medical Intelligence Medizintechnik GmbH as applicant

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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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