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FDA 510(k)

NEOLEAD

K-Number: K011564 · 2002-01-03

ApplicantNeotech Products, Inc.
Decision Date2002-01-03
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEOLEAD is the device name listed in this FDA 510(k) record. The listed applicant is Neotech Products, Inc.. It received FDA 510(k) clearance on 2002-01-03 under 510(k) number K011564. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOLEAD?

NEOLEAD is a medical device that received FDA 510(k) clearance on 2002-01-03. The listed applicant is Neotech Products, Inc.. The 510(k) number is K011564.

When did NEOLEAD receive FDA 510(k) clearance?

NEOLEAD received FDA 510(k) clearance on 2002-01-03, under 510(k) number K011564.

Who is the listed applicant for NEOLEAD?

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

What is the FDA product code for NEOLEAD?

The FDA product code for NEOLEAD is DRX.

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Other records listing Neotech Products, Inc. as applicant

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Related Devices (Code: DRX)

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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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