K897171 is an FDA 510(k) clearance for the DISPOSABLE CO2 ABSORBER/E. This device is classified as a Absorbent, Carbon-dioxide (Class I - General Controls, product code CBL).
Submitted by Gibeck, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 13, 1990, 75 days after receiving the submission on December 28, 1989.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5300.
| 510(k) Number | K897171 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1989 |
| Decision Date | March 13, 1990 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CBL — Absorbent, Carbon-dioxide |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5300 |