Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RE-ENTRANT CHAMBER, MODEL 1008 OR 44D

K-Number: K002446 · 2000-10-23

ApplicantSun Nuclear Corp.
Decision Date2000-10-23
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RE-ENTRANT CHAMBER, MODEL 1008 OR 44D is the device name listed in this FDA 510(k) record. The listed applicant is Sun Nuclear Corp.. It received FDA 510(k) clearance on 2000-10-23 under 510(k) number K002446. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RE-ENTRANT CHAMBER, MODEL 1008 OR 44D?

RE-ENTRANT CHAMBER, MODEL 1008 OR 44D is a medical device that received FDA 510(k) clearance on 2000-10-23. The listed applicant is Sun Nuclear Corp.. The 510(k) number is K002446.

When did RE-ENTRANT CHAMBER, MODEL 1008 OR 44D receive FDA 510(k) clearance?

RE-ENTRANT CHAMBER, MODEL 1008 OR 44D received FDA 510(k) clearance on 2000-10-23, under 510(k) number K002446.

Who is the listed applicant for RE-ENTRANT CHAMBER, MODEL 1008 OR 44D?

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

What is the FDA product code for RE-ENTRANT CHAMBER, MODEL 1008 OR 44D?

The FDA product code for RE-ENTRANT CHAMBER, MODEL 1008 OR 44D is KXK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sun Nuclear Corp. 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.

K112981SUN 125C IONIZATION CHAMBERK1019923D SCANNER, MODEL 1230K092019MODEL 1014 PC ELECTROMETERK063021PROFILER 2K051921THE EDGE DETECTOR, MODEL 1118K013689RE-ENTRANT CHAMBER

View all 13 devices →

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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.

↑