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Sensoronics

FDA UDI

Class II (US FDA UDI)

by Sensoronics Incorporated

Identity

Trade Name
Sensoronics FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Model / Reference
SB-NCRO-9A FDA UDI

Identifiers

Primary DI / UDI-DI
00851456007231 FDA UDI
510(k) Number
K083010 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximeter probe, reusable 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter probe, reusable

Sensoronics by Sensoronics Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K083010 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sensoronics Incorporated

Sources (1)

  • FDA UDI 59480450-a52b-496f-95e4-d5ebe3b372a5 33 fields · synced May 30, 2026