K991512 is an FDA 510(k) clearance for the ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X. This device is classified as a Dialyzer, Capillary, Hollow Fiber (Class II - Special Controls, product code FJI).
Submitted by Asahi Medical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on July 29, 1999, 90 days after receiving the submission on April 30, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K991512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1999 |
| Decision Date | July 29, 1999 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJI — Dialyzer, Capillary, Hollow Fiber |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |