ARES 610 Unicorder System

FDA UDI

Class II (US FDA UDI)

by WATERMARK MEDICAL Inc

Identity

Trade Name: ARES 610 Unicorder System FDA UDI
Generic Name: Analytical non-scalp cutaneous electrode FDA UDI
Device Name: ARES 610 HST Recorder and disposables FDA UDI
Model / Reference: 610 FDA UDI
Description: ARES 610 HST Recorder and disposables FDA UDI

Identifiers

Catalog Number: WMU 1610-001 FDA UDI
Primary DI / UDI-DI: 00854485007098 FDA UDI
510(k) Number: K110705 FDA UDI
K111194 FDA UDI
K112514 FDA UDI
FDA Product Code: NFB FDA UDI
MNR FDA UDI
ETN FDA UDI
GMDN Term: Analytical non-scalp cutaneous electrode FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 FDA UDI
868.2375 FDA UDI
874.1820 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nasal oxygen cannula, basic Analytical non-scalp cutaneous electrode Home-use sleep apnoea recording system Skin-cleaning wipe, sterile

ARES 610 Unicorder System by WATERMARK MEDICAL Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K110705 also covers:

K111194 also covers:

K112514 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: WATERMARK MEDICAL Inc

Sources (1)

FDA UDI b0452a4a-96b0-499d-b4d9-37ac31b581b8 37 fields · synced Jun 1, 2026