The following data is part of a premarket notification filed by Medica Corp. with the FDA for Eastlyte Na/k/ca/ph.
| Device ID | K112788 |
| 510k Number | K112788 |
| Device Name: | EASTLYTE NA/K/CA/PH |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORP. 5 OAK PARK DRIVE Bedford, MA 01730 |
| Product Code | CEM |
| Subsequent Product Code | CHL |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-26 |
| Decision Date | 2011-10-20 |