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LCD Benchtop Assembly w/ Monitor & Fixation Camera

FDA UDI

Class II (US FDA UDI)

by Diagnosys Llc

Identity

Trade Name
LCD Benchtop Assembly w/ Monitor & Fixation Camera FDA UDI
Generic Name
Electroretinograph FDA UDI
Device Name
The LCD Monitor is a pattern stimulator component that can only be used as part of the D310 & D315. FDA UDI
Model / Reference
D359 FDA UDI
Description
The LCD Monitor is a pattern stimulator component that can only be used as part of the D310 & D315. FDA UDI

Identifiers

Primary DI / UDI-DI
00855730007382 FDA UDI
510(k) Number
K863956 FDA UDI
FDA Product Code
GWE FDA UDI
GMDN Term
Electroretinograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electroretinograph

LCD Benchtop Assembly w/ Monitor & Fixation Camera by Diagnosys Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroretinograph.

Cleared under the same submission

K863956 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnosys Llc

Sources (1)

  • FDA UDI f8ebaddc-ca56-4032-83af-7c005b283696 35 fields · synced Jun 1, 2026