NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
FDA 510(k) clearance K982928 · decided 1999-01-06
Clearance details
- K-number
- K982928
- Device name
- NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
- Applicant
- Radiometer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-20
- Decision date
- 1999-01-06
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Westlake, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of bl recall (Z-1406-06) | Radiometer America Inc | 2006-08-26 |
| Dri-Tek BG-OX Cartridge, Model #D7120, Cat. #946-003 Cartridges used in the NPT7 Analyzer, recall (Z-1261-06) | Radiometer America Inc | 2006-07-27 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S004) | Radiometer America, Inc. | 1986-02-21 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S003) | Radiometer America, Inc. | 1985-02-22 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S002) | Radiometer America, Inc. | 1984-03-01 |
| RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S001) | Radiometer America, Inc. | 1981-09-21 |