EasyOne Pro
Catalogue number 3000-1, listed by NDD Medizintechnik AG, Switzerland, under Calculator, Predicted Values, Pulmonary Function. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Homesun Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | NDD Medizintechnik AG, Switzerland |
|---|---|
| FDA product code | BTY |
| Device type | Calculator, Predicted Values, Pulmonary Function |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1890 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K091428 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 50 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment temperature 5 to 40 °C; Handling environment humidity 15 to 95 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3000-1 | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K161534 | 2017-02-22 |
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.