Hemosphere Foresight Module

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: HEMOSPHERE FORESIGHT MODULE FDA UDI
Generic Name: Tissue saturation oximeter FDA UDI
Device Name: HEMOSPHERE FORESIGHT MODULE FDA UDI
Model / Reference: HEMFSM10 FDA UDI
Description: HEMOSPHERE FORESIGHT MODULE FDA UDI

Identifiers

Catalog Number: HEMFSM10 FDA UDI
Primary DI / UDI-DI: 00690103208573 FDA UDI
510(k) Number: K180003 FDA UDI
K213682 FDA UDI
FDA Product Code: MUD FDA UDI
DQK FDA UDI
DQE FDA UDI
QAQ FDA UDI
DXN FDA UDI
DSB FDA UDI
QMS FDA UDI
FLL FDA UDI
GMDN Term: Tissue saturation oximeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
870.1425 FDA UDI
870.1230 FDA UDI
870.2210 FDA UDI
870.1130 FDA UDI
870.2770 FDA UDI
870.5600 FDA UDI
880.2910 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: General-purpose multi-parameter bedside monitor Tissue saturation oximeter

Hemosphere Foresight Module by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue saturation oximeter.

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FORE-SIGHT ELITE — Cas Medical Systems, Inc. · Class II
Clarifi Imaging System — MODULATED IMAGING, INC. · Class II
Spectros T-Stat — Spectros Corporation · Class II
FORE-SIGHT ELITE® — Cas Medical Systems, Inc. · Class II
SnapshotNIR — Kent Imaging Inc · 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: Edwards Lifesciences LLC

Sources (1)

FDA UDI 526b217f-6e33-4415-a890-9bfdd557e86c 38 fields · synced Jun 8, 2026