The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Carbon Dioxide.
Device ID | K060295 |
510k Number | K060295 |
Device Name: | CARBON DIOXIDE |
Classification | Enzymatic, Carbon-dioxide |
Applicant | ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038 |
Contact | Linda Morris |
Correspondent | Linda Morris ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038 |
Product Code | KHS |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-06 |
Decision Date | 2006-05-04 |
Summary: | summary |