Spirotrac
The FDA filing identifies Spirotrac as a PC-based medical software application for creating, adding, and recalling subjects and performing spirometry testing. It can link with compatible…
The FDA filing identifies Spirotrac as a PC-based medical software application for creating, adding, and recalling subjects and performing spirometry testing. It can link with compatible third-party devices to read and display their output.
The summary lists spirometry measurements from single-breath and multiple-breath techniques, including recording lung volumes and flow rates. It also names inspiratory and expiratory flow measurements and pre- and post-testing.
Listed Item
7000 Spirotrac
Testing and Data Links
Spirotrac can integrate and display information from pulse oximetry, blood-pressure, weight, and ECG devices.
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 | Vitalograph Ireland Ltd., Ireland |
|---|---|
| FDA product code | BZG |
| Device type | Spirometer, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1840 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K141546 |
| Record published | 2021-04-30 |
| Record revised | 2022-03-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7000 | In distribution | |
| 7000 | In distribution | |
| 7000 | In distribution | |
| 7000 | In distribution | |
| 7000 | In distribution |
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 |
|---|---|
| K212938 | 2022-01-26 |
| K201562 | 2020-10-14 |
| K200550 | 2020-07-27 |
| K160253 | 2016-08-26 |
| K142642 | 2015-06-30 |
| K142812 | 2015-06-29 |
| K141546 | 2014-09-03 |
| K100687 | 2010-10-16 |
| K073155 | 2008-06-04 |
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.