The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Co2 Content.
Device ID | K800111 |
510k Number | K800111 |
Device Name: | CO2 CONTENT |
Classification | Cresol Red Colorimetry, Carbon-dioxide |
Applicant | AMERICAN MONITOR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIL |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-16 |
Decision Date | 1980-02-13 |