The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Co 2 Meter.
Device ID | K792155 |
510k Number | K792155 |
Device Name: | CO 2 METER |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | BOEHRINGER LABORATORIES 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 | 1979-10-24 |
Decision Date | 1979-11-27 |