Xltek

FDA UDI

Class II (US FDA UDI)

by Embla Systems

Identity

Trade Name: Xltek FDA UDI
Generic Name: Multiple physiological signal amplifier FDA UDI
Device Name: P32 Pulse Oxi LP Cable FDA UDI
Model / Reference: 011291 FDA UDI
Description: P32 Pulse Oxi LP Cable FDA UDI

Identifiers

Primary DI / UDI-DI: 00382830024662 FDA UDI
510(k) Number: K122516 FDA UDI
FDA Product Code: MNR FDA UDI
GMDN Term: Multiple physiological signal amplifier FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2375 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

FDA UDI

Category: Multiple physiological signal amplifier

Xltek by Embla Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K122516 also covers:

Xltek — Embla Systems

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: Embla Systems

Sources (1)

FDA UDI c517de98-4de6-487b-9157-ccaf92505589 34 fields · synced May 31, 2026