FDA 510(k)

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-

K-Number: K983720 · 1999-05-17

Decision Date1999-05-17

Product CodeMSE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

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- 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 1999-05-17 under 510(k) number K983720. The device is classified under product code MSE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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-?

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- is a medical device that received FDA 510(k) clearance on 1999-05-17. The listed applicant is Asahi Medical Co., Ltd.. The 510(k) number is K983720.

When did 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- receive FDA 510(k) clearance?

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- received FDA 510(k) clearance on 1999-05-17, under 510(k) number K983720.

Who is the listed applicant for 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-?

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-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-?

The FDA product code for 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- is MSE.

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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)K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X K970650ASAHI AM-R SERIES DIALYZERS K914020MODIFIED ASAHI PAN-SERIES HEMOFILTERS

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Related Devices (Code: MSE)

K001685PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210Baxter Healthcare Corp K970700FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUXFresenius USA, Inc.K97409095 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERSFresenius Medical Care North America K970661CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)Baxter Healthcare Corp K970654CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)Baxter Healthcare Corp K970650ASAHI AM-R SERIES DIALYZERSAsahi Medical Co., Ltd.

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.