Compact
The Vitalograph Model 6600 Compact is a spirometer intended for use by or on the order of a physician in a hospital or clinic. The filing describes it for adults and children aged five…
The Vitalograph Model 6600 Compact is a spirometer intended for use by or on the order of a physician in a hospital or clinic. The filing describes it for adults and children aged five years and older.
It measures respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The filing also describes connecting compatible Vitalograph or third-party devices.
Listed Item
Generic Clinical Trial Case – MIP MEP COMPACT(1)
Measurements and Output
The filing says the Compact can acquire, view, store and print connected device output. It describes the Model 6600 as using a touch screen interface and producing reports to external printers.
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) | K142642 |
| Record published | 2023-02-10 |
| Record revised | 2022-03-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature 0 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6600 | In distribution | |
| 6600 | In distribution | |
| 6600 | In distribution | |
| 6600 | 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.