The following data is part of a premarket notification filed by Erich Jaeger, Inc. with the FDA for Co2 Test.
Device ID | K843844 |
510k Number | K843844 |
Device Name: | CO2 TEST |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | ERICH JAEGER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Ronald Evenson |
Correspondent | Ronald Evenson ERICH JAEGER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-01 |
Decision Date | 1984-10-12 |