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FDA 510(k)

T-Stat 2.0 Microvascular Tissue Oximeter

K-Number: K192322 · 2019-09-23

ApplicantSpectros Corporation
Decision Date2019-09-23
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T-Stat 2.0 Microvascular Tissue Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Spectros Corporation. It received FDA 510(k) clearance on 2019-09-23 under 510(k) number K192322. 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 T-Stat 2.0 Microvascular Tissue Oximeter?

T-Stat 2.0 Microvascular Tissue Oximeter is a medical device that received FDA 510(k) clearance on 2019-09-23. The listed applicant is Spectros Corporation. The 510(k) number is K192322.

When did T-Stat 2.0 Microvascular Tissue Oximeter receive FDA 510(k) clearance?

T-Stat 2.0 Microvascular Tissue Oximeter received FDA 510(k) clearance on 2019-09-23, under 510(k) number K192322.

Who is the listed applicant for T-Stat 2.0 Microvascular Tissue Oximeter?

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

What is the FDA product code for T-Stat 2.0 Microvascular Tissue Oximeter?

The FDA product code for T-Stat 2.0 Microvascular Tissue Oximeter is MUD.

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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