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FDA 510(k)

FLOWCARE SYSTEM

K-Number: K041882 · 2004-11-23

ApplicantPointcare Technologies, Inc.
Decision Date2004-11-23
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FLOWCARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pointcare Technologies, Inc.. It received FDA 510(k) clearance on 2004-11-23 under 510(k) number K041882. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWCARE SYSTEM?

FLOWCARE SYSTEM is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Pointcare Technologies, Inc.. The 510(k) number is K041882.

When did FLOWCARE SYSTEM receive FDA 510(k) clearance?

FLOWCARE SYSTEM received FDA 510(k) clearance on 2004-11-23, under 510(k) number K041882.

Who is the listed applicant for FLOWCARE SYSTEM?

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

What is the FDA product code for FLOWCARE SYSTEM?

The FDA product code for FLOWCARE SYSTEM is GKZ.

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Other records listing Pointcare Technologies, 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.

K072869POINTCARE NOW SYSTEM

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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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