Aquarius TT with Evox

FDA UDI

Class II (US FDA UDI)

by Laborie Medical Technologies Canada ULC

Identity

Trade Name: Aquarius TT with Evox FDA UDI
Generic Name: Evoked-potential graphic recording system FDA UDI
Model / Reference: PRO177 FDA UDI

Identifiers

Primary DI / UDI-DI: 00627825004275 FDA UDI
510(k) Number: K082614 FDA UDI
FDA Product Code: JXE FDA UDI
GWF FDA UDI
GMDN Term: Evoked-potential graphic recording system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1550 FDA UDI
882.1870 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Evoked-potential graphic recording system

Aquarius TT with Evox by Laborie Medical Technologies Canada ULC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Neuropack — NIHON KOHDEN AMERICA, INC. · Class II
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Cleared under the same submission

K082614 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: Laborie Medical Technologies Canada ULC

Sources (1)

FDA UDI 56a30aa5-0c05-45d4-a828-dfa1b3abb987 33 fields · synced May 30, 2026