The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Aeroset System.
| Device ID | K980367 |
| 510k Number | K980367 |
| Device Name: | AEROSET SYSTEM |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | ABBOTT LABORATORIES 1920 HURD DRIVE Irving, TX 75038 |
| Contact | Andrew Johnson |
| Correspondent | Andrew Johnson ABBOTT LABORATORIES 1920 HURD DRIVE Irving, TX 75038 |
| Product Code | CGZ |
| Subsequent Product Code | CEM |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-29 |
| Decision Date | 1998-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740019327 | K980367 | 000 |