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FDA 510(k)

PURE COMPANY FLUID DELIVERY SYSTEM

K-Number: K971278 · 1997-07-03

ApplicantPure Co.
Decision Date1997-07-03
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PURE COMPANY FLUID DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pure Co.. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K971278. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURE COMPANY FLUID DELIVERY SYSTEM?

PURE COMPANY FLUID DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Pure Co.. The 510(k) number is K971278.

When did PURE COMPANY FLUID DELIVERY SYSTEM receive FDA 510(k) clearance?

PURE COMPANY FLUID DELIVERY SYSTEM received FDA 510(k) clearance on 1997-07-03, under 510(k) number K971278.

Who is the listed applicant for PURE COMPANY FLUID DELIVERY SYSTEM?

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

What is the FDA product code for PURE COMPANY FLUID DELIVERY SYSTEM?

The FDA product code for PURE COMPANY FLUID DELIVERY SYSTEM is EIA.

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Related Devices (Code: EIA)

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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