Who else makes this device?

Name: MasimoSET® Lnop® TC-I SpO2 Reusable Ear Sensor
Brand: MasimoSET® Lnop® TC-I SpO2 Reusable Ear Sensor

Cardiovascular › MonitoringOximeter, Ear

MasimoSET® Lnop® TC-I SpO2 Reusable Ear Sensor

Catalogue number 1794, listed by Masimo Corporation, United States, under Oximeter, Ear. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1), Sichuan (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DPZ
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Measurement Specialties Chengdu	Chengdu	Sichuan	Contract manufacturer	3
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for MasimoSET® Lnop® TC-I SpO2 Reusable Ear Sensor
Listed by	Masimo Corporation, United States
FDA product code	DPZ
Device type	Oximeter, Ear
Device class	Class 2
Regulation	21 CFR 870.2710
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2016-08-23
Record revised	2021-11-10 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for MasimoSET® Lnop® TC-I SpO2 Reusable Ear Sensor
Catalogue number	Size	Status
1794		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
TruSignal SpO2	GE Healthcare Finland OY	16
Oximeter, Ear	GE Healthcare Finland OY	9
Ear sensor	Honeywell Healthcare Solutions GmbH	8
BCI	ICU Medical, Inc	3
TruSignal SpO2	GE Medical Systems, LLC	2
103164 tCOM+	Sentec AG	1
Multi-Site Attachment Ring for mature/intact skin	Sentec AG	1
Sentec Digital Monitor	Sentec AG	1
Contact Gel	Sentec AG	1
103421 Sensor Adapter Cable (Long)	Sentec AG	1
Digital Sensor Adapter Cable, 250 cm	Sentec AG	1
Non-Adhesive Wrap	Sentec AG	1

Showing 12 of 40. All products under Oximeter, Ear

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of MasimoSET® Lnop® TC-I SpO2 Reusable Ear Sensor
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Masimo Corporation	UDI-DI	2023-04-21	Class II	Nonconforming Material/Component	TC-I tip clip sensor may produce readings outside the accuracy specification.	86 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.