K800 Amplifier

FDA UDI

Class II (US FDA UDI)

by Biometrics Limited

Identity

Trade Name: K800 Amplifier FDA UDI
Generic Name: Multiple physiological signal amplifier FDA UDI
Device Name: A modern microprocessor controlled general purpose amplifier system which is designed to be worn by the subject. The Amplifier (K800) provides a user friendly method for collecting signals from a variety of sensors including goniometers, sEMG and related signals, in a format which may readily be connected to proprietary display and recording systems including A/D cards. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI
Model / Reference: K800 FDA UDI
Description: A modern microprocessor controlled general purpose amplifier system which is designed to be worn by the subject. The Amplifier (K800) provides a user friendly method for collecting signals from a variety of sensors including goniometers, sEMG and related signals, in a format which may readily be connected to proprietary display and recording systems including A/D cards. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13 FDA UDI

Identifiers

Primary DI / UDI-DI: 05060481692199 FDA UDI
FDA Product Code: IKK FDA UDI
KQX FDA UDI
GMDN Term: Multiple physiological signal amplifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1925 FDA UDI
888.1500 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple physiological signal amplifier

K800 Amplifier by Biometrics Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Biometrics Limited

Sources (1)

FDA UDI 8f6e0e08-2715-4806-806e-67e09a356b1f 33 fields · synced Jun 8, 2026