ASAHI AM-R SERIES DIALYZERS— 510(k) K970650
Substantially EquivalentAsahi Medical Co., Ltd.
FDA 510(k) clearance K970650 for ASAHI AM-R SERIES DIALYZERS, Substantially Equivalent on 1997-09-30. Applicant: Asahi Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Asahi Medical Co., Ltd.
- Product code
- Code MSE
- 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 MSE
view all- K001685 — PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
- 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-
- K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
- K974090 — 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
- K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
More 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)
- K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
- K914020 — MODIFIED ASAHI PAN-SERIES HEMOFILTERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.