Precision Medical
1900 SERIES,REG,O2,EP5,HOMEFILL,NON-CE
1manufacturer
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Precision Medical Technologies, United States |
|---|---|
| FDA product code | NFB |
| Device type | Conserver, Oxygen |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2024-12-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19HF05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Conserver, Oxygen | Salter Labs | 23 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 20 |
| AirLife™ | Airlife, Inc. | 17 |
| AirLife™ | Vyaire Medical, Inc. | 13 |
| Evolution | Inovo Inc. | 11 |
| Bonsai | Inovo Inc. | 9 |
| drive | Drive DeVilbiss Healthcare | 7 |
| Economizer Conserving Regulator | Inovo Inc. | 4 |
| Oxymizer | Inovo Inc. | 3 |
| Medline | Medline Industries, Inc. | 2 |
| Drive | Inovo Inc. | 2 |
| AirLife | Carefusion | 2 |
Showing 12 of 29. All products under Conserver, Oxygen
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K032018 | 2003-08-25 |
| K001412 | 2001-03-20 |
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.