Micro
The Vitalograph Model 6300 micro is a handheld spirometer for assessing respiratory function. The FDA filing says it measures lung volumes and flow rates, including FVC, FEV1, FEV6, PEF,…
The Vitalograph Model 6300 micro is a handheld spirometer for assessing respiratory function. The FDA filing says it measures lung volumes and flow rates, including FVC, FEV1, FEV6, PEF, MVV and VC.
The filing describes use for lung function testing in adults and children aged five years and older. Testing may take place in hospitals, health centers or private homes under a healthcare provider’s supervision.
Listed Item
6300 Micro Bluetooth International WEST(1)
Respiratory Measurements
The filing describes a flowhead with a Fleisch pneumotachograph. Airflow creates a pressure difference that a pressure transducer converts into a signal for digital calculation and display.
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) | K160253 |
| Record published | 2017-02-21 |
| Record revised | 2022-03-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Storage environment temperature 0 to 50 °C; Storage environment humidity 10 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6300 | In distribution | |
| 6300 | In distribution | |
| 6300 | In distribution | |
| 6300 | In distribution | |
| 6300 | 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.