ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X— 510(k) K991512
Substantially EquivalentAsahi Medical Co., Ltd.
FDA 510(k) clearance K991512 for ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X, Substantially Equivalent on 1999-07-29. Applicant: Asahi Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Asahi Medical Co., Ltd.
- Product code
- Code FJI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code FJI
view allMore clearances from Asahi Medical Co., Ltd.
view all- K041726 — HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
- K013418 — AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
- K001250 — APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
- K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
- K970650 — ASAHI AM-R SERIES DIALYZERS
Adverse events under product code FJI
product code FJI- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.