NorLab
For calibration of Blood Gas Analyzers in accordance with Manufacturers Instruction.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
Record
| Listed by | Norco, Inc., United States |
|---|---|
| FDA product code | LCH |
| Device type | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Manufacturer |
| 510(k) | K904163 |
| Record published | 2022-12-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Medical Blood Gas | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K904163 | 1990-11-01 |
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.