The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Abl520 Blood Gas System.
| Device ID | K910827 |
| 510k Number | K910827 |
| Device Name: | ABL520 BLOOD GAS SYSTEM |
| Classification | Assay, Carboxyhemoglobin |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Donald L Baker |
| Correspondent | Donald L Baker RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | GHS |
| CFR Regulation Number | 864.7425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-27 |
| Decision Date | 1991-07-09 |