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FDA 510(k)

RFA-300, LDA UTILITY

K-Number: K961400 · 1997-01-03

ApplicantScanditronix Medical AB
Decision Date1997-01-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RFA-300, LDA UTILITY is the device name listed in this FDA 510(k) record. The listed applicant is Scanditronix Medical AB. It received FDA 510(k) clearance on 1997-01-03 under 510(k) number K961400. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RFA-300, LDA UTILITY?

RFA-300, LDA UTILITY is a medical device that received FDA 510(k) clearance on 1997-01-03. The listed applicant is Scanditronix Medical AB. The 510(k) number is K961400.

When did RFA-300, LDA UTILITY receive FDA 510(k) clearance?

RFA-300, LDA UTILITY received FDA 510(k) clearance on 1997-01-03, under 510(k) number K961400.

Who is the listed applicant for RFA-300, LDA UTILITY?

The FDA 510(k) record lists Scanditronix Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RFA-300, LDA UTILITY?

The FDA product code for RFA-300, LDA UTILITY is IYE.

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 Scanditronix Medical AB 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.

K011763OMNIDOSK002051INVIDOSK990734DPD-12PCC

Related Devices (Code: IYE)

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.

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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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