The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Abl System 625, 615, 605.
| Device ID | K954612 |
| 510k Number | K954612 |
| Device Name: | ABL SYSTEM 625, 615, 605 |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Donald L Baker |
| Correspondent | Donald L Baker RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-05 |
| Decision Date | 1995-11-09 |