The following data is part of a premarket notification filed by Smash Ent., Inc. with the FDA for Ionometer Ef And Accessories.
Device ID | K870183 |
510k Number | K870183 |
Device Name: | IONOMETER EF AND ACCESSORIES |
Classification | Electrode, Ion Specific, Sodium |
Applicant | SMASH ENT., INC. 5871 OXFORD ST. Shoreview, MN 55125 |
Contact | Steven V Bush |
Correspondent | Steven V Bush SMASH ENT., INC. 5871 OXFORD ST. Shoreview, MN 55125 |
Product Code | JGS |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-16 |
Decision Date | 1987-05-12 |