The following data is part of a premarket notification filed by Deka Research And Development with the FDA for Amia Automated Pd System With Sharesource.
| Device ID | K151525 |
| 510k Number | K151525 |
| Device Name: | Amia Automated PD System With Sharesource |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | DEKA RESEARCH AND DEVELOPMENT 340 COMMERCIAL ST. Manchester, NH 03101 |
| Contact | Roger Leroux |
| Correspondent | Roger Leroux DEKA RESEARCH AND DEVELOPMENT 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 | 2015-06-08 |
| Decision Date | 2015-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085412529776 | K151525 | 000 |
| 00085412490120 | K151525 | 000 |
| 05413765565694 | K151525 | 000 |
| 25413765565698 | K151525 | 000 |
| 15413765565691 | K151525 | 000 |