Who else makes this device?

Name: Atos
Brand: Atos

Atos · Device, Positive Pressure Breathing, Intermittent → Anesthesiology

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NHJ
Manufacturer	City	Province	Registered as	Device types
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29

Record

Regulatory record for Atos
Listed by	Respironics Inc., United States
FDA product code	NHJ
Device type	Device, Positive Pressure Breathing, Intermittent
Device class	Class 2
Regulation	21 CFR 868.5905
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K121955
Record published	2016-01-22
Record revised	2024-12-20 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	serial number
Storage	Storage environment humidity 15 to 95 % RH; Storage environment temperature -20 to 60 °C

Catalogue Numbers

Catalogue numbers for Atos
Catalogue number	Size	Status
70		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
CoughAssist	Respironics Inc.	44
Percussionaire	Percussionaire Corp.	40
The MetaNeb®System	Hill-Rom Services Pte, Ltd.	14
The VitalCough®System	Hill-Rom Services Pte, Ltd.	10
Synclara Cough System	Hill-Rom Services Pte, Ltd.	10
Volara System	Hill-Rom Services Pte, Ltd.	9
Vocsn Patient Breathing Package	Ventec Life Systems, Inc.	7
Clearo	Breas Medical, Inc.	6
Maximus System	Hill-Rom Services Pte, Ltd.	6
BiWaze Clear Dual Lumen Circuit With Face Mask – Adult Small	Abmrc LLC	3
BiWaze Cough Dual Lumen Circuit With Face Mask – Adult Large	Abmrc LLC	3
The Vest APX System	Hill-Rom Services Pte, Ltd.	2

Showing 12 of 32. All products under Device, Positive Pressure Breathing, Intermittent

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K121955	2012-12-14

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.

Atos