Fore-Sight Elite Absolute Tissue Oximeter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133879 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 designed to monitor cerebral tissue oxygen saturation. It utilizes near-infrared light projected through the scalp and skull to analyze reflected light and display oxygen saturation levels as an absolute number.
This device provides a graphical representation of historical values to assist in clinical monitoring. It is regulated under FDA 510(k) clearance and is intended for use with a disposable sensor applied to the patient's forehead.
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, Benchtop cerebral oximeter - FORE-SIGHT ELITE - CAS Medical Systems ..., Casmed fore-sight elite Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133879 | Class II | Active |
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Manufacturer
- Manufacturer
- Cas Medical Systems, Inc.
Sources (1)
- FDA 510(k) K133879 24 fields · synced Sep 26, 2026