K896127 is an FDA 510(k) clearance for the THORA-KLEX CHEST DRAINAGE UNIT. This device is classified as a Bottle, Collection, Vacuum (Class II - Special Controls, product code KDQ).
Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on January 24, 1990, 93 days after receiving the submission on October 23, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K896127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1989 |
| Decision Date | January 24, 1990 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KDQ — Bottle, Collection, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |