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FDA 510(k)

AIW WATER SYSTEM FOR HEMODIALYSIS

K-Number: K001282 · 2000-12-15

ApplicantAmerican Industrial Water
Decision Date2000-12-15
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AIW WATER SYSTEM FOR HEMODIALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is American Industrial Water. It received FDA 510(k) clearance on 2000-12-15 under 510(k) number K001282. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIW WATER SYSTEM FOR HEMODIALYSIS?

AIW WATER SYSTEM FOR HEMODIALYSIS is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is American Industrial Water. The 510(k) number is K001282.

When did AIW WATER SYSTEM FOR HEMODIALYSIS receive FDA 510(k) clearance?

AIW WATER SYSTEM FOR HEMODIALYSIS received FDA 510(k) clearance on 2000-12-15, under 510(k) number K001282.

Who is the listed applicant for AIW WATER SYSTEM FOR HEMODIALYSIS?

The FDA 510(k) record lists American Industrial Water as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIW WATER SYSTEM FOR HEMODIALYSIS?

The FDA product code for AIW WATER SYSTEM FOR HEMODIALYSIS is FIP.

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Related Devices (Code: FIP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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