The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Enzymatic Co2.
| Device ID | K822079 |
| 510k Number | K822079 |
| Device Name: | ENZYMATIC CO2 |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | AMERICAN MONITOR CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-15 |
| Decision Date | 1982-07-27 |