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FDA 510(k)

EIGEN FLORO-STOR FS-100

K-Number: K844375 · 1985-03-26

ApplicantEigen Video
Decision Date1985-03-26
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EIGEN FLORO-STOR FS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Eigen Video. It received FDA 510(k) clearance on 1985-03-26 under 510(k) number K844375. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EIGEN FLORO-STOR FS-100?

EIGEN FLORO-STOR FS-100 is a medical device that received FDA 510(k) clearance on 1985-03-26. The listed applicant is Eigen Video. The 510(k) number is K844375.

When did EIGEN FLORO-STOR FS-100 receive FDA 510(k) clearance?

EIGEN FLORO-STOR FS-100 received FDA 510(k) clearance on 1985-03-26, under 510(k) number K844375.

Who is the listed applicant for EIGEN FLORO-STOR FS-100?

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

What is the FDA product code for EIGEN FLORO-STOR FS-100?

The FDA product code for EIGEN FLORO-STOR FS-100 is JAA.

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 Eigen Video 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.

K935026DIGITAL MEDIA CONVERTER (D-MC)K942264DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)K850080DIGITAL IMAGE PROCESSOR FP-2C

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

Official Source

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