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FDA 510(k)

SIMULIX-MC CT EXTENSION

K-Number: K932848 · 1994-03-22

ApplicantOldelft Corp. of America
Decision Date1994-03-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIMULIX-MC CT EXTENSION 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 1994-03-22 under 510(k) number K932848. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMULIX-MC CT EXTENSION?

SIMULIX-MC CT EXTENSION is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Oldelft Corp. of America. The 510(k) number is K932848.

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

SIMULIX-MC CT EXTENSION received FDA 510(k) clearance on 1994-03-22, under 510(k) number K932848.

Who is the listed applicant for SIMULIX-MC CT EXTENSION?

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-MC CT EXTENSION?

The FDA product code for SIMULIX-MC CT EXTENSION is JAK.

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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 HFK923584THERAPAX DXT 300 SERIES 3K914784PAPILLION PROCTOSCOPE

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Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, 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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