K905448 is an FDA 510(k) clearance for the THORA-KLEX CHEST DRAINAGE UNIT. This device is classified as a Apparatus, Suction, Operating-room, Wall Vacuum Powered (Class II - Special Controls, product code GCX).
Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on March 27, 1991, 112 days after receiving the submission on December 5, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K905448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1990 |
| Decision Date | March 27, 1991 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | GCX — Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |