Arc Essentia

FDA UDI

Class II (US FDA UDI)

by Cadwell Industries, Inc.

Identity

Trade Name: Arc Essentia FDA UDI
Generic Name: Electroencephalograph FDA UDI
Device Name: ESSENTIA REMOTE INPUT CABLE, 10FT FDA UDI
Model / Reference: 199283-000-010 FDA UDI
Description: ESSENTIA REMOTE INPUT CABLE, 10FT FDA UDI

Identifiers

Primary DI / UDI-DI: 00840067102817 FDA UDI
510(k) Number: K133355 FDA UDI
FDA Product Code: GWQ FDA UDI
OMC FDA UDI
GWE FDA UDI
OLV FDA UDI
GWL FDA UDI
OLT FDA UDI
GMDN Term: Electroencephalograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 FDA UDI
882.1890 FDA UDI
882.1835 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: Electroencephalograph

Arc Essentia by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroencephalograph.

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Natus — Natus Neurology Incorporated · Class II
Sleep Profiler PSG2 — Advanced Brain Monitoring, Inc. · Class II
Natus — Natus Neurology Incorporated · Class II
128-channel EEG cap (L) — Megin Oy · Class II
Compumedics Neuvo — COMPUMEDICS LIMITED · Class II
Zeto ONE Head Unit - Small — ZETO INC · Class II

Cleared under the same submission

K133355 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: Cadwell Industries, Inc.

Sources (1)

FDA UDI d3340dcd-1c0c-4676-9029-00d0488b5126 35 fields · synced Jun 9, 2026