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FDA 510(k)

SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100

K-Number: K000249 · 2000-12-11

ApplicantSchaefer Water Centers
Decision Date2000-12-11
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Schaefer Water Centers. It received FDA 510(k) clearance on 2000-12-11 under 510(k) number K000249. 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 SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100?

SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 is a medical device that received FDA 510(k) clearance on 2000-12-11. The listed applicant is Schaefer Water Centers. The 510(k) number is K000249.

When did SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 receive FDA 510(k) clearance?

SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 received FDA 510(k) clearance on 2000-12-11, under 510(k) number K000249.

Who is the listed applicant for SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100?

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

What is the FDA product code for SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100?

The FDA product code for SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100 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

View on FDA Database →

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

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