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FDA 510(k)

OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM

K-Number: K073656 · 2008-01-25

ApplicantHypermed, Inc.
Decision Date2008-01-25
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hypermed, Inc.. It received FDA 510(k) clearance on 2008-01-25 under 510(k) number K073656. 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 OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM?

OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-25. The listed applicant is Hypermed, Inc.. The 510(k) number is K073656.

When did OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM receive FDA 510(k) clearance?

OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM received FDA 510(k) clearance on 2008-01-25, under 510(k) number K073656.

Who is the listed applicant for OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM?

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

What is the FDA product code for OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM?

The FDA product code for OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYSTEM is MUD.

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.

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Other records listing Hypermed, 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.

K061848HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1

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

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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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