Spirowin
The SPIROWIN Expert software is used with the Q13 electronic spirometer to explore respiratory function. It acquires samples from the spirometer and determines flow and volume so curves and…
The SPIROWIN Expert software is used with the Q13 electronic spirometer to explore respiratory function. It acquires samples from the spirometer and determines flow and volume so curves and results can be displayed.
On the attached PC, the software calculates, displays, and stores data for practitioners exploring respiratory function. The Q13 connects to the computer through a USB lead and uses a single-use sensor.
Use With the Q13
The FDA filing describes the Q13 as a portable spirometer for clinical spirometry in adults and children aged six years and above. It states that the software and results are for trained health professionals.
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Fujian (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Intersurgical Medical Apparatus (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 12 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Flexible Circuit Technologies Shenzhen | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Feellife Health Inc. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | FIM Medical, France |
|---|---|
| FDA product code | BZG |
| Device type | Spirometer, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1840 |
| Establishment | Manufacturer |
| 510(k) | K161676 |
| Record published | 2022-03-16 |
| Record revised | 2022-06-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Distribution end date | 2022-05-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EXPERT DEPISTEO | In distribution | |
| EXPERT DEPISTEO | In distribution | |
| Expert | In distribution | |
| Expert | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Polytech Filter | Polytechnic Resources, Inc. | 190 |
| Model 4000 | Vitalograph Ireland Ltd. | 115 |
| Astra Spirometer | S D I Diagnostics Inc | 90 |
| MIR | Mir Medical International Research | 56 |
| Curaplex | TRI-Anim Health Services, Inc. | 55 |
| Alpha | Vitalograph Ireland Ltd. | 48 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 47 |
| MGC Diagnostics | Medical Graphics Corp. | 42 |
| Astraguard | S D I Diagnostics Inc | 39 |
| PFT | Vitalograph Ireland Ltd. | 38 |
| Vyaire | Jaeger Medical GmbH | 36 |
| BVF | Vitalograph Ireland Ltd. | 29 |
Showing 12 of 123. All products under Spirometer, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161676 | 2016-10-20 |
| K050424 | 2005-06-23 |
| K010761 | 2002-03-05 |
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.