The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Sodium And Potassium By Ion Selective.
Device ID | K873074 |
510k Number | K873074 |
Device Name: | SODIUM AND POTASSIUM BY ION SELECTIVE |
Classification | Electrode, Ion Specific, Sodium |
Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
Contact | Luann Ochs |
Correspondent | Luann Ochs AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
Product Code | JGS |
CFR Regulation Number | 862.1665 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-06 |
Decision Date | 1987-10-20 |