510(k) K771263
- Device
- RADIOMHTER OSM-2 HEMOXIMETER
- Applicant
- The London Co.
- 510(k) number
- K771263
- Product code
- GHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-03
- Date received
- 1977-07-11
- Regulation
- 864.7425
- Classification name
- Assay, Carboxyhemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3014506106
- 1220649
- 3037000637
- 3023162659
- 3002807968
- 2431530
- 3007490412
- 9610126
- 3013513377
- 3006198300
- 3003795116
- 1219029
- 1217183
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GHS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974805 | CO-STAT(TM) END TIDAL BREATH ANALYZER | Natus Medical, Inc. | 1998-03-11 |
| K910827 | ABL520 BLOOD GAS SYSTEM | Radiometer America, Inc. | 1991-07-09 |
| K790943 | TRISEDTA-BORATE ELECTROPHORESIS FILM AGA | Corning Medical & Scientific | 1979-06-22 |
| K770209 | ECOLYZER CARBOXIMETER | Iadec, Inc. | 1977-03-07 |