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FDA 510(k)

MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX

K-Number: K001052 · 2000-08-30

ApplicantMed-Tec,Inc.
Decision Date2000-08-30
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tec,Inc.. It received FDA 510(k) clearance on 2000-08-30 under 510(k) number K001052. 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 MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX?

MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX is a medical device that received FDA 510(k) clearance on 2000-08-30. The listed applicant is Med-Tec,Inc.. The 510(k) number is K001052.

When did MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX receive FDA 510(k) clearance?

MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX received FDA 510(k) clearance on 2000-08-30, under 510(k) number K001052.

Who is the listed applicant for MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX?

The FDA 510(k) record lists Med-Tec,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX?

The FDA product code for MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX is IYE.

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Other records listing Med-Tec,Inc. 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.

K034054PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100K031866MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DACK021360SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000K023293MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02K013875MED-TEC COMPENSATOR BLOCK CUTTER SOFTWAREK981992ELECTRON WEDGE MODEL MT-EW-1000

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Related Devices (Code: IYE)

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.

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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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