← Back to catalogue

Dolphin

FDA UDI

Class II (US FDA UDI)

by Osi Optoelectronics, Inc.

Identity

Trade Name
Dolphin FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
Adult Resuable Oximetry Sensor FDA UDI
Model / Reference
2010 FDA UDI
Description
Adult Resuable Oximetry Sensor FDA UDI

Identifiers

Primary DI / UDI-DI
00859998006071 FDA UDI
510(k) Number
K030952 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

No

FDA UDI

Prescription Use

Yes

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

Category: Pulse oximeter probe, reusable

Dolphin by Osi Optoelectronics, Inc. — 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

K030952 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Osi Optoelectronics, Inc.

Sources (1)

  • FDA UDI 6c5faaea-ff10-4a1f-ac13-2b4301bb52f1 34 fields · synced May 30, 2026