HSA · registration DE0510207Spectros T-Stat 2.0 Microvascular Tissue Oximeter with accessories
- Registration number
- DE0510207
- Model name
- 2.5 cm Surface Sensor CTH-060-SUR 2.5CM; 1 cm Surface Sensor CTH-060-SUR 1CM, box of 5; 1 cm Surface Sensor CTH-060-SUR 1CM; 2.3m Endoscopic Sensor CTH-060-ENDO, box of 5; 2.3m Endoscopic Sensor CTH-060-ENDO; Oral Sensor CTH-060-ORA M, box of 5; Oral Sensor CTH-060-ORA M; T-Stat 2.0; 2.5 cm Surface Sensor CTH-060-SUR 2.5CM, box of 5
- Model identifier
- 851136007001; 851136007015; 851136007018; 851136007022; 851136007025; 851136007046; 851136007049; 851136007056; 861136007008
- Registration date
- January 03, 2025
- Risk class
- Class B
- Product owner
- Spectros Medical Devices, Inc.
- Registrant / registration holder
- HUMEDICAL (S) PTE. LTD.
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.
- Product owner address
- 2211 Norfolk St. STE 1110, Houston, Texas, 77098, United States
- Registrant address
- 3791 JALAN BUKIT MERAH, #06-17, E-CENTRE @ REDHILL, Singapore 159471
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.