The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Abl 735 Analyzer.
| Device ID | K991417 |
| 510k Number | K991417 |
| Device Name: | ABL 735 ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Vince Sigmund |
| Correspondent | Vince Sigmund RADIOMETER AMERICA, INC. 810 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CIG |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | MQM |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-23 |
| Decision Date | 1999-11-24 |
| Summary: | summary |