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FDA 510(k)

HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES

K-Number: K873487 · 1987-10-23

ApplicantWater Pure, Inc.
Decision Date1987-10-23
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Water Pure, Inc.. It received FDA 510(k) clearance on 1987-10-23 under 510(k) number K873487. 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 HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES?

HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES is a medical device that received FDA 510(k) clearance on 1987-10-23. The listed applicant is Water Pure, Inc.. The 510(k) number is K873487.

When did HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES receive FDA 510(k) clearance?

HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES received FDA 510(k) clearance on 1987-10-23, under 510(k) number K873487.

Who is the listed applicant for HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES?

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

What is the FDA product code for HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES?

The FDA product code for HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES is FIP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Water Pure, Inc. as applicant

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.

K863720HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES

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.

K250471AquaC UNO HFresenius Medical Care Renal Therapies Group, LLCK251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLCK252181AquaAFresenius Medical Care North AmericaK250514UPT Series Medical RO Water Treatment SystemSpecialty Water Technologies, Inc.K232953AquaBplus; AquaB LITEFresenius Medical Care Renal Therapies Group, LLCK223479AQUAbase nXB.Braun Medical, Inc.

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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