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SnapshotNIR

FDA UDI

Class II (US FDA UDI)

by Kent Imaging Inc

Identity

Trade Name
SnapshotNIR FDA UDI
Generic Name
Tissue saturation oximeter FDA UDI
Device Name
Tissue oxygenation imaging device FDA UDI
Model / Reference
KD204 FDA UDI
Description
Tissue oxygenation imaging device FDA UDI

Identifiers

Primary DI / UDI-DI
B376KD2040 FDA UDI
510(k) Number
K201976 FDA UDI
FDA Product Code
MUD FDA UDI
GMDN Term
Tissue saturation oximeter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Tissue saturation oximeter

SnapshotNIR by Kent Imaging Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue saturation oximeter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kent Imaging Inc

Sources (1)

  • FDA UDI a1d72e7e-af2d-4033-b8bd-70557e6764e7 34 fields · synced May 30, 2026