The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Cd-102 Carbon Dioxide Analyzer/recor.
Device ID | K833739 |
510k Number | K833739 |
Device Name: | CD-102 CARBON DIOXIDE ANALYZER/RECOR |
Classification | Analyzer, Gas, Carbon-monoxide, Gaseous-phase |
Applicant | INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
Product Code | CCJ |
CFR Regulation Number | 868.1430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-25 |
Decision Date | 1983-12-16 |