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FDA 510(k)

SIMULIX-HP

K-Number: K946128 · 1995-05-12

ApplicantOldelft Corp. of America
Decision Date1995-05-12
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIMULIX-HP 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 1995-05-12 under 510(k) number K946128. 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 SIMULIX-HP?

SIMULIX-HP is a medical device that received FDA 510(k) clearance on 1995-05-12. The listed applicant is Oldelft Corp. of America. The 510(k) number is K946128.

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

SIMULIX-HP received FDA 510(k) clearance on 1995-05-12, under 510(k) number K946128.

Who is the listed applicant for SIMULIX-HP?

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 SIMULIX-HP?

The FDA product code for SIMULIX-HP 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 DUK950037N 800 HFK932848SIMULIX-MC CT EXTENSIONK923584THERAPAX DXT 300 SERIES 3K914784PAPILLION PROCTOSCOPE

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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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