510(k) K124018
K124018 is an FDA 510(k) premarket notification submitted by Deka Research & Development Corp. for the device "AMIA AUTOMATED PD SYSTEM". The FDA issued a decision of Substantially Equivalent on June 14, 2013. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Deka Research & Development Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2013
- Date Received
- December 27, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Peritoneal, Automatic Delivery
- Device Class
- Class II
- Regulation Number
- 876.5630
- Review Panel
- GU
- Submission Type