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FDA 510(k)

MODIFICATION TO HL168

K-Number: K033043 · 2003-10-10

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

Device Summary

MODIFICATION TO HL168 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 2003-10-10 under 510(k) number K033043. 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 MODIFICATION TO HL168?

MODIFICATION TO HL168 is a medical device that received FDA 510(k) clearance on 2003-10-10. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K033043.

When did MODIFICATION TO HL168 receive FDA 510(k) clearance?

MODIFICATION TO HL168 received FDA 510(k) clearance on 2003-10-10, under 510(k) number K033043.

Who is the listed applicant for MODIFICATION TO HL168?

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 MODIFICATION TO HL168?

The FDA product code for MODIFICATION TO HL168 is DXN.

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

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Related Devices (Code: DXN)

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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