The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Osm3 Hemoximeter.
| Device ID | K853990 |
| 510k Number | K853990 |
| Device Name: | OSM3 HEMOXIMETER |
| Classification | Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-monoxide |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Gerald L Vedaa |
| Correspondent | Gerald L Vedaa RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | JKS |
| CFR Regulation Number | 862.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-27 |
| Decision Date | 1985-12-30 |