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FDA 510(k)

DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES

K-Number: K905111 · 1991-01-25

ApplicantEigen
Decision Date1991-01-25
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 1991-01-25 under 510(k) number K905111. 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 DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES?

DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES is a medical device that received FDA 510(k) clearance on 1991-01-25. The listed applicant is Eigen. The 510(k) number is K905111.

When did DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES receive FDA 510(k) clearance?

DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES received FDA 510(k) clearance on 1991-01-25, under 510(k) number K905111.

Who is the listed applicant for DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES?

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

What is the FDA product code for DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES?

The FDA product code for DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES is JAA.

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Other records listing Eigen 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.

K222222Artemis, Artemis TPO, Artemis MXK173744ProFuse CADK162474ArtemisK063846EIGEN DSA 2000K933115DIGITAL DISK RECORDERK924164DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPT

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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

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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