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FDA 510(k)

EFILM VIDEO

K-Number: K013631 · 2001-11-20

ApplicantEfilm Medical, Inc.
Decision Date2001-11-20
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EFILM VIDEO is the device name listed in this FDA 510(k) record. The listed applicant is Efilm Medical, Inc.. It received FDA 510(k) clearance on 2001-11-20 under 510(k) number K013631. 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 EFILM VIDEO?

EFILM VIDEO is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is Efilm Medical, Inc.. The 510(k) number is K013631.

When did EFILM VIDEO receive FDA 510(k) clearance?

EFILM VIDEO received FDA 510(k) clearance on 2001-11-20, under 510(k) number K013631.

Who is the listed applicant for EFILM VIDEO?

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

What is the FDA product code for EFILM VIDEO?

The FDA product code for EFILM VIDEO 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 Efilm Medical, 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.

K020995EFILM WORKSTATION WITH MODULESK012211EFILM WORKSTATION

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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