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FDA 510(k)

DIOBEAM 830

K-Number: K031499 · 2003-09-16

ApplicantSoft-Core Texas, Inc.
Decision Date2003-09-16
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DIOBEAM 830 is the device name listed in this FDA 510(k) record. The listed applicant is Soft-Core Texas, Inc.. It received FDA 510(k) clearance on 2003-09-16 under 510(k) number K031499. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIOBEAM 830?

DIOBEAM 830 is a medical device that received FDA 510(k) clearance on 2003-09-16. The listed applicant is Soft-Core Texas, Inc.. The 510(k) number is K031499.

When did DIOBEAM 830 receive FDA 510(k) clearance?

DIOBEAM 830 received FDA 510(k) clearance on 2003-09-16, under 510(k) number K031499.

Who is the listed applicant for DIOBEAM 830?

The FDA 510(k) record lists Soft-Core Texas, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIOBEAM 830?

The FDA product code for DIOBEAM 830 is NHN.

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 Soft-Core Texas, Inc. 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.

K002991ZAP DUAL CURING LIGHT

Related Devices (Code: NHN)

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.

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia CorporationK252273Therapy USDmc Importação E Exportação DE Equipamentos LtdaK241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos LtdaK231409Erchonia FX-405Erchonia Corporation

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.

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