Who else makes this device?

Name: FlowScreen
Brand: FlowScreen

Anesthesiology › DiagnosticCalculator, Predicted Values, Pulmonary Function

FlowScreen

diagnostic spirometer for recording and assessing pulmonary function

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

3510(k) clearances naming this product code

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 FlowScreen
Listed by	eResearchTechnology GmbH, Germany
FDA product code	BTY
Device type	Calculator, Predicted Values, Pulmonary Function
Device class	Class 2
Regulation	21 CFR 868.1890
Establishment	Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K080734
Record published	2016-07-15
Record revised	2024-03-19 (version 6)

Specifications

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

Catalogue Numbers

Catalogue numbers for FlowScreen
Catalogue number	Size	Status
FlowScreen		In distribution
FlowScreen CT		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
K223629	2024-05-28
K202754	2021-01-28
K173937	2019-02-15

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.