The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Carbon Dioxide.
| Device ID | K872886 |
| 510k Number | K872886 |
| Device Name: | CARBON DIOXIDE |
| Classification | Phenolphthalein Colorimetry, Carbon-dioxide |
| Applicant | CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
| Contact | Luis P Leon |
| Correspondent | Luis P Leon CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
| Product Code | KMS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-22 |
| Decision Date | 1987-08-13 |