510(k) K873074

SODIUM AND POTASSIUM BY ION SELECTIVE by American Monitor Corp. — Product Code JGS

K873074 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "SODIUM AND POTASSIUM BY ION SELECTIVE". The FDA issued a decision of Substantially Equivalent on October 20, 1987. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. American Monitor Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1987
Date Received
August 6, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type