FDA 510(k)

OEC 901

K-Number: K942841 · 1994-08-09

Decision Date1994-08-09

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OEC 901 is the device name listed in this FDA 510(k) record. The listed applicant is Baldwin. It received FDA 510(k) clearance on 1994-08-09 under 510(k) number K942841. 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 OEC 901?

OEC 901 is a medical device that received FDA 510(k) clearance on 1994-08-09. The listed applicant is Baldwin. The 510(k) number is K942841.

When did OEC 901 receive FDA 510(k) clearance?

OEC 901 received FDA 510(k) clearance on 1994-08-09, under 510(k) number K942841.

Who is the listed applicant for OEC 901?

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

What is the FDA product code for OEC 901?

The FDA product code for OEC 901 is JAA.

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 Corporation K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC K242488Soteria E-ViewOmega Medical Imaging, LLC K242948Adora DRFi (04550010)Nrt X-Ray A/S K233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech America K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.