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FDA 510(k)

HOWTEK 960

K-Number: K970908 · 1997-05-20

ApplicantHowtek, Inc.
Decision Date1997-05-20
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HOWTEK 960 is the device name listed in this FDA 510(k) record. The listed applicant is Howtek, Inc.. It received FDA 510(k) clearance on 1997-05-20 under 510(k) number K970908. 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 HOWTEK 960?

HOWTEK 960 is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is Howtek, Inc.. The 510(k) number is K970908.

When did HOWTEK 960 receive FDA 510(k) clearance?

HOWTEK 960 received FDA 510(k) clearance on 1997-05-20, under 510(k) number K970908.

Who is the listed applicant for HOWTEK 960?

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 HOWTEK 960?

The FDA product code for HOWTEK 960 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K021949FULCRUMK973081DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)K972191DIGITIZER DIRECTOR (HSC025-01)K953117SCANMASTER 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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