FDA 510(k)

ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X

K-Number: K991512 · 1999-07-29

Decision Date1999-07-29

Product CodeFJI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Medical Co., Ltd.. It received FDA 510(k) clearance on 1999-07-29 under 510(k) number K991512. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X?

ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X is a medical device that received FDA 510(k) clearance on 1999-07-29. The listed applicant is Asahi Medical Co., Ltd.. The 510(k) number is K991512.

When did ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X receive FDA 510(k) clearance?

ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X received FDA 510(k) clearance on 1999-07-29, under 510(k) number K991512.

Who is the listed applicant for ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X?

The FDA 510(k) record lists Asahi Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X?

The FDA product code for ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X is FJI.

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Other records listing Asahi Medical Co., Ltd. as applicant

K041726HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX K013418AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY K001250APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)K983720ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-K970650ASAHI AM-R SERIES DIALYZERS K914020MODIFIED ASAHI PAN-SERIES HEMOFILTERS

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Related Devices (Code: FJI)

K190459Hemoflow F3 and F4 DialyzersFresenius Medical Care Renal Therapies Group, LLC K122952NIPRO PUREFLUX-L HEMODIALYZERNipro Medical Corporation K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRGambro Renal Products K010366DISPOSABLE STORAGE CAPMolded Products, Inc.K011148ULTRACONCENTRATOR SYSTEMInterpore Cross Intl.K002761FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERSFresenius Medical Care North America

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.