The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Accelerator Aps.
| Device ID | K093318 |
| 510k Number | K093318 |
| Device Name: | ACCELERATOR APS |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | ABBOTT LABORATORIES 1920 HURD DRIVE LC-2, MS 1-8 Irving, TX 75038 |
| Contact | Mark Littlefield |
| Correspondent | Mark Littlefield ABBOTT LABORATORIES 1920 HURD DRIVE LC-2, MS 1-8 Irving, TX 75038 |
| Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-23 |
| Decision Date | 2010-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740028862 | K093318 | 000 |
| 00380740015091 | K093318 | 000 |