K921803 is an FDA 510(k) clearance for the SOFNOLIME CARBON DIOXIDE ABSORBENT. This device is classified as a Absorbent, Carbon-dioxide (Class I - General Controls, product code CBL).
Submitted by Molecular Products , Ltd. (Thaxted, Essex, GB). The FDA issued a Cleared decision on October 15, 1992, 183 days after receiving the submission on April 15, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5300.
| 510(k) Number | K921803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1992 |
| Decision Date | October 15, 1992 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBL — Absorbent, Carbon-dioxide |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5300 |