Phoenix EEG Amplifier

FDA UDI

Class II (US FDA UDI)

by Southeast Signal, Inc

Identity

Trade Name: Phoenix EEG Amplifier FDA UDI
Generic Name: Multiple physiological signal amplifier FDA UDI
Device Name: EEG Amplifier FDA UDI
Model / Reference: A202 FDA UDI
Description: EEG Amplifier FDA UDI

Identifiers

Primary DI / UDI-DI: B58802E0 FDA UDI
510(k) Number: K071661 FDA UDI
FDA Product Code: HCC FDA UDI
GMDN Term: Multiple physiological signal amplifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple physiological signal amplifier

Phoenix EEG Amplifier by Southeast Signal, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K071661 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: Southeast Signal, Inc

Sources (1)

FDA UDI bd726ff8-fcef-4ecb-b2da-398dce0f06a4 35 fields · synced May 30, 2026