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FDA 510(k)

T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303

K-Number: K040684 · 2004-11-05

ApplicantSpectros Corporation
Decision Date2004-11-05
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 is the device name listed in this FDA 510(k) record. The listed applicant is Spectros Corporation. It received FDA 510(k) clearance on 2004-11-05 under 510(k) number K040684. 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 MICROVASCULAR TISSUE OXIMETER, MODEL 303?

T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 is a medical device that received FDA 510(k) clearance on 2004-11-05. The listed applicant is Spectros Corporation. The 510(k) number is K040684.

When did T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 receive FDA 510(k) clearance?

T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 received FDA 510(k) clearance on 2004-11-05, under 510(k) number K040684.

Who is the listed applicant for T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303?

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 MICROVASCULAR TISSUE OXIMETER, MODEL 303?

The FDA product code for T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 is MUD.

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Other records listing Spectros Corporation 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.

K192322T-Stat 2.0 Microvascular Tissue OximeterK081233T-STAT 303 ISCHEMIA MONITORING SYSTEM

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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