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FDA 510(k)

BODYFIX

K-Number: K013391 · 2002-01-11

ApplicantMedical Intelligence Medizintechnik GmbH
Decision Date2002-01-11
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BODYFIX 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 2002-01-11 under 510(k) number K013391. 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 BODYFIX?

BODYFIX is a medical device that received FDA 510(k) clearance on 2002-01-11. The listed applicant is Medical Intelligence Medizintechnik GmbH. The 510(k) number is K013391.

When did BODYFIX receive FDA 510(k) clearance?

BODYFIX received FDA 510(k) clearance on 2002-01-11, under 510(k) number K013391.

Who is the listed applicant for BODYFIX?

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 BODYFIX?

The FDA product code for BODYFIX is IYE.

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Other records listing Medical Intelligence Medizintechnik GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121530BODYFIX SYSTEMK112210FRAXIONK072898HEXAPOD EVO RT COUCH TOPK071870HEXAPOD RT COUCH TOPK041448HEXAPOD RT COUCHTOPK030439HEADFIX

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Related Devices (Code: IYE)

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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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