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FDA 510(k)

PSC-1 W/OTHER NUMERICAL

K-Number: K903821 · 1990-11-07

ApplicantEigen
Decision Date1990-11-07
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PSC-1 W/OTHER NUMERICAL is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 1990-11-07 under 510(k) number K903821. 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 PSC-1 W/OTHER NUMERICAL?

PSC-1 W/OTHER NUMERICAL is a medical device that received FDA 510(k) clearance on 1990-11-07. The listed applicant is Eigen. The 510(k) number is K903821.

When did PSC-1 W/OTHER NUMERICAL receive FDA 510(k) clearance?

PSC-1 W/OTHER NUMERICAL received FDA 510(k) clearance on 1990-11-07, under 510(k) number K903821.

Who is the listed applicant for PSC-1 W/OTHER NUMERICAL?

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 PSC-1 W/OTHER NUMERICAL?

The FDA product code for PSC-1 W/OTHER NUMERICAL 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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