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FDA 510(k)

OLDELFT SIMULIX-MC

K-Number: K912466 · 1991-06-28

ApplicantOldelft Corp. of America
Decision Date1991-06-28
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLDELFT SIMULIX-MC is the device name listed in this FDA 510(k) record. The listed applicant is Oldelft Corp. of America. It received FDA 510(k) clearance on 1991-06-28 under 510(k) number K912466. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLDELFT SIMULIX-MC?

OLDELFT SIMULIX-MC is a medical device that received FDA 510(k) clearance on 1991-06-28. The listed applicant is Oldelft Corp. of America. The 510(k) number is K912466.

When did OLDELFT SIMULIX-MC receive FDA 510(k) clearance?

OLDELFT SIMULIX-MC received FDA 510(k) clearance on 1991-06-28, under 510(k) number K912466.

Who is the listed applicant for OLDELFT SIMULIX-MC?

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

What is the FDA product code for OLDELFT SIMULIX-MC?

The FDA product code for OLDELFT SIMULIX-MC is KPQ.

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Other records listing Oldelft Corp. of America 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.

K980296OLDELFT DIGIDELCAK973219AMBER DUK946128SIMULIX-HPK950037N 800 HFK932848SIMULIX-MC CT EXTENSIONK923584THERAPAX DXT 300 SERIES 3

View all 9 devices →

Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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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