510(k) K130131
K130131 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "EDRAIN CHEST DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 28, 2013. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2013
- Date Received
- January 18, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Portable, Aspiration (Manual Or Powered)
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type