Who else makes this device?

Name: BresoDX1BresoHub
Brand: BresoDX1BresoHub

Anesthesiology › MonitoringVentilatory Effort Recorder

BresoDX1BresoHub

BresoHub is a component of BresoDX1. During a test, BresoHub is placed at the patient’s bedside to receive the data from BresoSensor and the pulse oximeter wirelessly, and it stores the…

Registry build 21.09.26

BresoHub is a component of BresoDX1. During a test, BresoHub is placed at the patient’s bedside to receive the data from BresoSensor and the pulse oximeter wirelessly, and it stores the data locally. BresoHub is powered by a provided power supply. This device is only sold USA.

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Fujian (1), Jiangsu (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MNR
Manufacturer	City	Province	Registered as	Device types
Sanbor Medical Xiamen, Inc.	Xiamen	Fujian	Contract manufacturer	16
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Mehow Innovative (Huizhou) Ltd.	Huizhou	Guangdong	Contract manufacturer	11

Record

Regulatory record for BresoDX1BresoHub
Listed by	Bresotec, Inc., Canada
FDA product code	MNR
Device type	Ventilatory Effort Recorder
Device class	Class 2
Regulation	21 CFR 868.2375
510(k)	K220012
Record published	2023-06-26

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for BresoDX1BresoHub
Catalogue number	Size	Status
BTSM1US-DCU		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sleepsense	S. L. P. Scientific Laboratory Products Ltd	182
TriplePlay	Dymedix Diagnostics Inc	71
Embla	S. L. P. Scientific Laboratory Products Ltd	36
Grass	S. L. P. Scientific Laboratory Products Ltd	31
Xltek	Embla Systems	30
Alice NightOne	Respironics Inc.	22
Onera STS	Onera B.V.	21
Natus	S. L. P. Scientific Laboratory Products Ltd	21
Night Shift	Advanced Brain Monitoring, Inc.	19
Neurovirtual	Neurovirtual USA, Inc.	18
SOMNOtouch Resp accessory	Somnomedics AG	18
zRIP	Respironics Inc.	17

Showing 12 of 259. All products under Ventilatory Effort Recorder

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K220012	2022-12-21

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.