The following data is part of a premarket notification filed by Deka Research & Development Corp. with the FDA for Amia Automated Pd System.
| Device ID | K124018 |
| 510k Number | K124018 |
| Device Name: | AMIA AUTOMATED PD SYSTEM |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | DEKA RESEARCH & DEVELOPMENT CORP. 340 COMMERCIAL ST. Manchester, NH 03101 |
| Contact | Roger A Leroux |
| Correspondent | Roger A Leroux DEKA RESEARCH & DEVELOPMENT CORP. 340 COMMERCIAL ST. Manchester, NH 03101 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-27 |
| Decision Date | 2013-06-14 |
| Summary: | summary |