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FDA 510(k)

FULCRUM

K-Number: K021949 · 2002-08-12

ApplicantHowtek, Inc.
Decision Date2002-08-12
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FULCRUM is the device name listed in this FDA 510(k) record. The listed applicant is Howtek, Inc.. It received FDA 510(k) clearance on 2002-08-12 under 510(k) number K021949. The device is classified under product code LMA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FULCRUM?

FULCRUM is a medical device that received FDA 510(k) clearance on 2002-08-12. The listed applicant is Howtek, Inc.. The 510(k) number is K021949.

When did FULCRUM receive FDA 510(k) clearance?

FULCRUM received FDA 510(k) clearance on 2002-08-12, under 510(k) number K021949.

Who is the listed applicant for FULCRUM?

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

What is the FDA product code for FULCRUM?

The FDA product code for FULCRUM is LMA.

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 Howtek, 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.

K973081DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)K972191DIGITIZER DIRECTOR (HSC025-01)K970908HOWTEK 960K953117SCANMASTER DX

Related Devices (Code: LMA)

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.

K132183DICOM VIDEOBar Code Computer, Ltd.K130636TELERADPRO EDGE; TELERADPRO EDGE HD-CCDVidar Systems Corp.K130406DIAGNOSTICPRO EDGEVidar Systems Corp.K102476TELERADPROVidar Systems Corp.K093809VIDAR DENTAL FILM DIGITIZERVidar Systems Corp.K091288MEDI-6000 MEDICAL IMAGE DIGITIZERMicrotek International, 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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