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FDA 510(k)

VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2

K-Number: K042657 · 2005-01-10

ApplicantVioptix, Inc.
Decision Date2005-01-10
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 is the device name listed in this FDA 510(k) record. The listed applicant is Vioptix, Inc.. It received FDA 510(k) clearance on 2005-01-10 under 510(k) number K042657. 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 VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2?

VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 is a medical device that received FDA 510(k) clearance on 2005-01-10. The listed applicant is Vioptix, Inc.. The 510(k) number is K042657.

When did VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 receive FDA 510(k) clearance?

VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 received FDA 510(k) clearance on 2005-01-10, under 510(k) number K042657.

Who is the listed applicant for VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2?

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

What is the FDA product code for VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2?

The FDA product code for VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 is MUD.

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Other records listing Vioptix, 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.

K250519Lap.Ox™ Laparoscopic Tissue OximeterK233488Intra.Ox™ 2.0 Handheld Tissue OximeterK221010Intra.Ox 2.0 Handheld Tissue OximeterK191676Intra.Ox 2.0 Handheld Tissue OximeterK163472Intra.Ox Handheld Tissue OximeterK090679VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM

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Related Devices (Code: MUD)

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.

K254129Spectrum-2Neko Health ABK243324Masimo O3 Regional OximeterMasimo CorporationK250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards LifesciencesK241393ODI-TechOdi Medical ASK240601SnapshotNIR model KD205Kent Imaging, Inc.

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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