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FDA 510(k)

OWL URF-3AP

K-Number: K062758 · 2006-09-27

ApplicantDiros Technology, Inc.
Decision Date2006-09-27
Product CodeGXD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OWL URF-3AP is the device name listed in this FDA 510(k) record. The listed applicant is Diros Technology, Inc.. It received FDA 510(k) clearance on 2006-09-27 under 510(k) number K062758. The device is classified under product code GXD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OWL URF-3AP?

OWL URF-3AP is a medical device that received FDA 510(k) clearance on 2006-09-27. The listed applicant is Diros Technology, Inc.. The 510(k) number is K062758.

When did OWL URF-3AP receive FDA 510(k) clearance?

OWL URF-3AP received FDA 510(k) clearance on 2006-09-27, under 510(k) number K062758.

Who is the listed applicant for OWL URF-3AP?

The FDA 510(k) record lists Diros Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OWL URF-3AP?

The FDA product code for OWL URF-3AP is GXD.

Other records listing Diros Technology, 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.

K170708OWL RF INSULATED CANNULAEK102566OWL CANNULAEK110593OWL RF PROBESK093185OWL UNIVERSAL RF SYSTEM URF-3AP (ML)K021869OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP

Related Devices (Code: GXD)

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.

K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)Boston Scientific Neuromodulation CorporationK242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc.K232632Racz Neurostat RF GeneratorEpimed InternationalK231675OneRF Ablation SystemNeuroone Medical Technologies Corp.K220122APEX 6Rf Innovations, Inc.K203293Abbott Medical Grounding Pad, model RF-DGP-ISABBOTT MEDICAL

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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