Fore-Sight Elite

FDA UDI

Class II (US FDA UDI)

by Cas Medical Systems, Inc.

Identity

Trade Name: FORE-SIGHT ELITE FDA UDI
Generic Name: Tissue saturation oximeter FDA UDI
Device Name: Tissue Oximeter Module FDA UDI
Model / Reference: 01-06-1000 FDA UDI
Description: Tissue Oximeter Module FDA UDI

Identifiers

Primary DI / UDI-DI: 10609538610001 FDA UDI
510(k) Number: K180003 FDA UDI
FDA Product Code: MUD FDA UDI
GMDN Term: Tissue saturation oximeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Tissue saturation oximeter

Fore-Sight Elite by Cas Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Spectros T-Stat — Spectros Corporation · Class II
SnapshotNIR — Kent Imaging Inc · Class II
MIMOSA — Mimosa Diagnostics, Inc. · Class II
INVOS — Covidien LP · Class II

Cleared under the same submission

K180003 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Cas Medical Systems, Inc.

Sources (1)

FDA UDI 8d0adc4d-2b26-48ea-b598-321e1f6ef15f 34 fields · synced May 31, 2026