Precision Medical Inc.
LX1900 Series Oxygen Conserving Regulator, Easy Pulse, Luxfer
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 | 2016-08-29 |
| Record revised | 2024-07-04 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2017-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LX1900 Series | Withdrawn |
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.