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FDA 510(k)

HUESTIS FLEXI-BOARD

K-Number: K904005 · 1990-11-29

ApplicantHuestis Machine Corp.
Decision Date1990-11-29
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HUESTIS FLEXI-BOARD is the device name listed in this FDA 510(k) record. The listed applicant is Huestis Machine Corp.. It received FDA 510(k) clearance on 1990-11-29 under 510(k) number K904005. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUESTIS FLEXI-BOARD?

HUESTIS FLEXI-BOARD is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Huestis Machine Corp.. The 510(k) number is K904005.

When did HUESTIS FLEXI-BOARD receive FDA 510(k) clearance?

HUESTIS FLEXI-BOARD received FDA 510(k) clearance on 1990-11-29, under 510(k) number K904005.

Who is the listed applicant for HUESTIS FLEXI-BOARD?

The FDA 510(k) record lists Huestis Machine Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HUESTIS FLEXI-BOARD?

The FDA product code for HUESTIS FLEXI-BOARD is JAD.

Related Clinical Trials

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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Other records listing Huestis Machine Corp. 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.

K940145COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICEK926187POSICAST IMMOBILIZATION SYSTEMK901567THE HUESTIS COMPU-PLOTTERK880047HUESTIS COMPU-FORMERK792721HUESTIS FLEXI-HOLDER

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, Inc.

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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