K830671 is an FDA 510(k) clearance for the THORAX-KLEX CHEST DRAINAGE UNIT. This device is classified as a Bottle, Collection, Vacuum (Class II - Special Controls, product code KDQ).
Submitted by C.R. Bard, Inc. (Warrendale, US). The FDA issued a Cleared decision on March 29, 1983, 25 days after receiving the submission on March 4, 1983.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K830671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1983 |
| Decision Date | March 29, 1983 |
| Days to Decision | 25 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 |