Radiomhter OSM-2 Hemoximeter
FDA 510(k) K771263 · The London Co.
510(k) numberK771263
Submission
- Device name
- Radiomhter OSM-2 Hemoximeter
- Applicant
- The London Co.
Mchenry, IL, US - Received
- July 11, 1977
- Decision date
- August 3, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GHS – Assay, Carboxyhemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7425
- Specialty
- Hematology
Other 510(k)s with product code GHS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974805 | Co-Stat(Tm) End Tidal Breath AnalyzerGHS · Traditional | Natus Medical, Inc. | 03/11/1998SE |
| K910827 | ABL520 Blood Gas SystemGHS · Traditional | Radiometer America, Inc. | 07/09/1991SE |
| K790943 | Trisedta-Borate Electrophoresis Film AgaGHS · Traditional | Corning Medical & Scientific | 06/22/1979SE |
| K770209 | Ecolyzer CarboximeterGHS · Traditional | Iadec, Inc. | 03/07/1977SE |
More from Iadec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802846 | TCM202 TCPO2 & TCM204 TCPO2/PO2 Rec. Sy.KLK · Traditional | 12/17/1980SE |
| K801848 | ICA1 Ionized Calcium AnalyzerJFP · Traditional | 10/31/1980SE |
| K800224 | Radiometer Acid Base LABORATORY-ABL-3CHL · Traditional | 02/22/1980SE |
| K780652 | Hemoglobin Check Solutions, S2100 OSM-2JKS · Traditional | 07/27/1978SE |
| K771444 | Qualicheck TMJJS · Traditional | 08/16/1977SE |
| K760229 | Acid Base System, Radiometer AutomatedCHL · Traditional | 08/26/1976SE |
Questions and answers
When was Radiomhter OSM-2 Hemoximeter cleared by the FDA?
Radiomhter OSM-2 Hemoximeter (K771263) received a 510(k) decision of Substantially Equivalent on August 3, 1977, 23 days after the submission was received.
What is the product code of K771263?
The FDA product code is GHS – Assay, Carboxyhemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7425.