ABL520 BLOOD GAS SYSTEM
FDA 510(k) clearance K910827 · decided 1991-07-09
Clearance details
- K-number
- K910827
- Device name
- ABL520 BLOOD GAS SYSTEM
- Applicant
- Radiometer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-02-27
- Decision date
- 1991-07-09
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- GHS
- Device class
- 2
- Regulation number
- 864.7425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Westlake, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| CO-STAT(TM) END TIDAL BREATH ANALYZER (K974805) | Natus Medical, Inc. | 1998-03-11 |
| TRISEDTA-BORATE ELECTROPHORESIS FILM AGA (K790943) | Corning Medical & Scientific | 1979-06-22 |
| RADIOMHTER OSM-2 HEMOXIMETER (K771263) | The London Co. | 1977-08-03 |
| ECOLYZER CARBOXIMETER (K770209) | Iadec, Inc. | 1977-03-07 |
Recalls involving this device
No recalls on record reference this clearance.
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 |