Who else makes this device?

Name: VitaloROV
Brand: VitaloROV

VitaloROV · Calculator, Predicted Values, Pulmonary Function → Anesthesiology

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code BTY
Manufacturer	City	Province	Registered as	Device types
Guangzhou Homesun Medical Technology Co., Ltd.	Guangzhou	Guangdong	Manufacturer	4

Record

Regulatory record for VitaloROV
Listed by	Vitalograph Ireland Ltd., Ireland
FDA product code	BTY
Device type	Calculator, Predicted Values, Pulmonary Function
Device class	Class 2
Regulation	21 CFR 868.1890
Establishment	Specification developer, Manufacturer
510(k)	K221030
Record published	2024-07-31

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number

Catalogue Numbers

Catalogue numbers for VitaloROV
Catalogue number	Size	Status
9100		In distribution
9100		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Vmax	Carefusion	59
Vmax	Vyaire Medical, Inc.	27
Jaeger	Jaeger Medical GmbH	16
SpiroSphere	eResearchTechnology GmbH	15
Vyaire	Jaeger Medical GmbH	8
Cosmed	C O S M E D SRL	8
MasterScope	eResearchTechnology GmbH	7
Shape-HF	Shape Medical Systems, Inc	3
Avea	Vyaire Medical, Inc.	3
Pneumotach	eResearchTechnology GmbH	2
ERT PT	eResearchTechnology GmbH	2
Shape	Shape Medical Systems, Inc	2

Showing 12 of 28. All products under Calculator, Predicted Values, Pulmonary Function

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K221030	2022-07-15

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.

VitaloROV