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FDA 510(k)

REALEYE MODEL VCPS

K-Number: K100625 · 2011-01-21

ApplicantNavotek Medical, Ltd.
Decision Date2011-01-21
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REALEYE MODEL VCPS is the device name listed in this FDA 510(k) record. The listed applicant is Navotek Medical, Ltd.. It received FDA 510(k) clearance on 2011-01-21 under 510(k) number K100625. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REALEYE MODEL VCPS?

REALEYE MODEL VCPS is a medical device that received FDA 510(k) clearance on 2011-01-21. The listed applicant is Navotek Medical, Ltd.. The 510(k) number is K100625.

When did REALEYE MODEL VCPS receive FDA 510(k) clearance?

REALEYE MODEL VCPS received FDA 510(k) clearance on 2011-01-21, under 510(k) number K100625.

Who is the listed applicant for REALEYE MODEL VCPS?

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

What is the FDA product code for REALEYE MODEL VCPS?

The FDA product code for REALEYE MODEL VCPS is IYE.

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.

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Other records listing Navotek Medical, 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.

K110971TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT

Related Devices (Code: IYE)

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

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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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