FDA 510(k)

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY

K-Number: K013418 · 2002-07-09

Decision Date2002-07-09

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY 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 2002-07-09 under 510(k) number K013418. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY?

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY is a medical device that received FDA 510(k) clearance on 2002-07-09. The listed applicant is Asahi Medical Co., Ltd.. The 510(k) number is K013418.

When did AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY receive FDA 510(k) clearance?

AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY received FDA 510(k) clearance on 2002-07-09, under 510(k) number K013418.

Who is the listed applicant for AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY?

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 AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY?

The FDA product code for AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY is KDI.

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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 K001250APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X 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: KDI)

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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.