The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Co2.
| Device ID | K981231 |
| 510k Number | K981231 |
| Device Name: | CO2 |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | ABBOTT MFG., INC. 1920 HURD DR. Irving, TX 75038 |
| Contact | Mark Litlefield |
| Correspondent | Mark Litlefield ABBOTT MFG., INC. 1920 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 | 1998-04-03 |
| Decision Date | 1998-05-12 |
| Summary: | summary |