Fore-Sight Elite Absolute Tissue Oximeter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123700 FDA 510(k)
- FDA Product Code
- MUD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fore-Sight Elite Absolute Tissue Oximeter is a device that measures cerebral tissue oxygen saturation levels. It uses near-infrared light to project through the scalp and skull and into the brain via a disposable sensor on the patient's forehead. The device displays the oxygen saturation level as an absolute number and provides a graphical representation of historical values.
The Fore-Sight Elite Absolute Tissue Oximeter is designed to accommodate both adult and pediatric patients and compensates for different optical properties and melanin effects. It is supplied with a disposable sensor and is intended for use in a clinical setting. The device has been authorized by the FDA under the 510K clearance type and is classified as a class 2 device with the regulation number 870.2700.
Frequently asked questions
What is the Fore-Sight Elite Absolute Tissue Oximeter used for?
The Fore-Sight Elite Absolute Tissue Oximeter is used to measure cerebral tissue oxygen saturation levels in both adult and pediatric patients, providing a graphical representation of historical values.
How is the device supplied?
The Fore-Sight Elite Absolute Tissue Oximeter is supplied with a disposable sensor for use on the patient's forehead.
Is the Fore-Sight Elite Absolute Tissue Oximeter suitable for different skin types?
Yes, the device compensates for different optical properties and melanin effects, making it suitable for use with various skin types.
What is the regulatory status of the Fore-Sight Elite Absolute Tissue Oximeter?
The device has been authorized by the FDA under the 510K clearance type and is classified as a class 2 device with the regulation number 870.2700.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CASMED FORE-SIGHT ELITE USER MANUAL Pdf Download, FORE-SIGHT ELITE Tissue Oximeter User Manual | Manualzz, Casmed fore-sight elite Manuals | ManualsLib, FORE-SIGHT ELITE Adult - CAS Medical Systems, Inc. CASMED - PDF ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123700 | Class II | Active |
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Manufacturer
- Manufacturer
- Cas Medical Systems, Inc.
Sources (1)
- FDA 510(k) K123700 24 fields · synced Sep 27, 2026