K130131 is an FDA 510(k) clearance for the EDRAIN CHEST DRAINAGE SYSTEM. This device is classified as a Pump, Portable, Aspiration (manual Or Powered) (Class II - Special Controls, product code BTA).
Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on February 28, 2013, 41 days after receiving the submission on January 18, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K130131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2013 |
| Decision Date | February 28, 2013 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | BTA — Pump, Portable, Aspiration (manual Or Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |