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FDA 510(k)

ESA LEADCARE II LEAD CONTROL

K-Number: K063398 · 2006-12-05

ApplicantBionostics, Inc.
Decision Date2006-12-05
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ESA LEADCARE II LEAD CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 2006-12-05 under 510(k) number K063398. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESA LEADCARE II LEAD CONTROL?

ESA LEADCARE II LEAD CONTROL is a medical device that received FDA 510(k) clearance on 2006-12-05. The listed applicant is Bionostics, Inc.. The 510(k) number is K063398.

When did ESA LEADCARE II LEAD CONTROL receive FDA 510(k) clearance?

ESA LEADCARE II LEAD CONTROL received FDA 510(k) clearance on 2006-12-05, under 510(k) number K063398.

Who is the listed applicant for ESA LEADCARE II LEAD CONTROL?

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

What is the FDA product code for ESA LEADCARE II LEAD CONTROL?

The FDA product code for ESA LEADCARE II LEAD CONTROL is DIF.

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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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