The following data is part of a premarket notification filed by Smash Ent., Inc. with the FDA for Ionometer E-hk And Accessories.
| Device ID | K880373 |
| 510k Number | K880373 |
| Device Name: | IONOMETER E-HK AND ACCESSORIES |
| Classification | Instrument, Hematocrit, Automated |
| Applicant | SMASH ENT., INC. 3585 LEXINGTON AVENUE NORTH SUITE 258 Arden Hills, MN 55126 |
| Contact | Steven V Busli |
| Correspondent | Steven V Busli SMASH ENT., INC. 3585 LEXINGTON AVENUE NORTH SUITE 258 Arden Hills, MN 55126 |
| Product Code | GKF |
| CFR Regulation Number | 864.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-27 |
| Decision Date | 1988-03-17 |