510(k) K802162

CO2 COLOR REAGENT & CO2 SAMPLE DILUENT by Panmed, Inc. — Product Code KMS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 8, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phenolphthalein Colorimetry, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type