The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Edrain Chest Drainage System.
| Device ID | K130131 |
| 510k Number | K130131 |
| Device Name: | EDRAIN CHEST DRAINAGE SYSTEM |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR Hudson, NH 03051 |
| Contact | Christina Calderwood |
| Correspondent | Christina Calderwood ATRIUM MEDICAL CORP. 5 WENTWORTH DR Hudson, NH 03051 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-18 |
| Decision Date | 2013-02-28 |