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FDA 510(k)

HL888 AF

K-Number: K032913 · 2003-10-02

ApplicantHealth & Life Co., Ltd.
Decision Date2003-10-02
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HL888 AF is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2003-10-02 under 510(k) number K032913. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HL888 AF?

HL888 AF is a medical device that received FDA 510(k) clearance on 2003-10-02. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K032913.

When did HL888 AF receive FDA 510(k) clearance?

HL888 AF received FDA 510(k) clearance on 2003-10-02, under 510(k) number K032913.

Who is the listed applicant for HL888 AF?

The FDA 510(k) record lists Health & Life Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HL888 AF?

The FDA product code for HL888 AF is DXN.

Other records listing Health & Life Co., Ltd. as applicant

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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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