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FDA 510(k)

Intra.Ox 2.0 Handheld Tissue Oximeter

K-Number: K221010 · 2022-05-03

ApplicantVioptix, Inc.
Decision Date2022-05-03
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Intra.Ox 2.0 Handheld Tissue Oximeter is a medical device manufactured by Vioptix, Inc.. It received FDA 510(k) clearance on 2022-05-03 under approval number K221010. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intra.Ox 2.0 Handheld Tissue Oximeter?

Intra.Ox 2.0 Handheld Tissue Oximeter is a medical device that received FDA 510(k) clearance on 2022-05-03. It is manufactured by Vioptix, Inc.. The 510(k) number is K221010.

When was Intra.Ox 2.0 Handheld Tissue Oximeter approved by the FDA?

Intra.Ox 2.0 Handheld Tissue Oximeter received FDA 510(k) clearance on 2022-05-03, under approval number K221010.

What company makes Intra.Ox 2.0 Handheld Tissue Oximeter?

Intra.Ox 2.0 Handheld Tissue Oximeter is manufactured by Vioptix, Inc..

What is the FDA product code for Intra.Ox 2.0 Handheld Tissue Oximeter?

The FDA product code for Intra.Ox 2.0 Handheld Tissue Oximeter is MUD.

Related Clinical Trials

NCT07605234 Phase II Single Arm Open Label Study Evaluating the Feasibility and Safety of Photobiomodulation as an Adjunct to Standard Supportive Care for Chemotherapy Induced Oral Mucositis in Pediatric Patients With Hematolymphoid Malignancies NOT_YET_RECRUITING NCT04859725 HyperSpectral Imaging in Low Grade Glioma ACTIVE_NOT_RECRUITING NCT06011252 Pacing Characteristics of a Conventional Bipolar ACTIVE_NOT_RECRUITING NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT03164122 EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA COMPLETED NCT06034847 Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy WITHDRAWN

Other Devices by Vioptix, Inc.

K163472Intra.Ox Handheld Tissue Oximeter K191676Intra.Ox 2.0 Handheld Tissue Oximeter K233488Intra.Ox™ 2.0 Handheld Tissue Oximeter

Related Devices (Code: MUD)

K153426Ox-Imager CSModulated Imaging, Inc. K161237HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc. K162117NIRO-200NX DPHamamatsu Photonics K.K. K160526Masimo O3 Regional Oximeter SystemMasimo Corporation K163472Intra.Ox Handheld Tissue OximeterVioptix, Inc. K162603Masimo O3 Regional Oximeter SystemMasimo 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.

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