Nonagon N9+

FDA UDI

Class II (US FDA UDI)

by Nonagon , Ltd.

Identity

Trade Name: Nonagon N9+ FDA UDI
Generic Name: Pulse oximeter FDA UDI
Model / Reference: N9+ FDA UDI

Identifiers

Primary DI / UDI-DI: 17290018446154 FDA UDI
510(k) Number: K202483 FDA UDI
FDA Product Code: DQD FDA UDI
DQA FDA UDI
ERA FDA UDI
FLL FDA UDI
GMDN Term: Pulse oximeter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1875 FDA UDI
870.2700 FDA UDI
874.4770 FDA UDI
880.2910 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: Infrared patient thermometer, skin Pulse oximeter Otoscope, direct Electronic acoustic stethoscope

Nonagon N9+ by Nonagon , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electronic acoustic stethoscope.

TytoHome — TYTO CARE LTD · Class II
3M™ Littmann® — 3M COMPANY · Class II
E-Scope — Cardionics, Inc. · Class II
Adscope® — American Diagnostic Corporation · Class II
TytoHome — TYTO CARE LTD · Class II
Adscope® — American Diagnostic Corporation · Class II
RNK Products — Rnk Products, Inc. · Class II
Eko Core Electronic Stethoscope — Eko Devices, Inc. · Class II

Cleared under the same submission

K202483 also covers:

Nonagon — Nonagon , Ltd.
Nonagon N9+ SmartExam — Nonagon , Ltd.

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

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

Manufacturer

Manufacturer: Nonagon , Ltd.

Sources (1)

FDA UDI bd3f8e36-f166-4851-aaa7-d8354223347c 33 fields · synced Jun 8, 2026