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FDA 510(k)

LIFELINES TRACKIT

K-Number: K010460 · 2001-05-14

Decision Date2001-05-14
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LIFELINES TRACKIT is the device name listed in this FDA 510(k) record. The listed applicant is Lifelines , Ltd.. It received FDA 510(k) clearance on 2001-05-14 under 510(k) number K010460. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFELINES TRACKIT?

LIFELINES TRACKIT is a medical device that received FDA 510(k) clearance on 2001-05-14. The listed applicant is Lifelines , Ltd.. The 510(k) number is K010460.

When did LIFELINES TRACKIT receive FDA 510(k) clearance?

LIFELINES TRACKIT received FDA 510(k) clearance on 2001-05-14, under 510(k) number K010460.

Who is the listed applicant for LIFELINES TRACKIT?

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

What is the FDA product code for LIFELINES TRACKIT?

The FDA product code for LIFELINES TRACKIT is OLV.

Related Clinical Trials

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.

Other records listing Lifelines , 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.

Related Devices (Code: OLV)

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.

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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