Spectros T-Stat 2.0 Microvascular Tissue Oximeter with accessories - HSA Registration DE0510207
Access comprehensive regulatory information for Spectros T-Stat 2.0 Microvascular Tissue Oximeter with accessories in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510207 and owned by Spectros Medical Devices, Inc.. The device was registered on January 03, 2025.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Spectros T-Stat 2.0 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states. The prospective clinical value of measurements made with the T-Stat Oximeter has not been demonstrated in disease states. The T-Stat Oximeter should not be used as the sole basis diagnosis or therapy.