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FDA 510(k)

NAVIAID BGE DEVICE, MODEL 21-001

K-Number: K060923 · 2006-08-15

ApplicantSmart Medical Systems , Ltd.
Decision Date2006-08-15
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NAVIAID BGE DEVICE, MODEL 21-001 is the device name listed in this FDA 510(k) record. The listed applicant is Smart Medical Systems , Ltd.. It received FDA 510(k) clearance on 2006-08-15 under 510(k) number K060923. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIAID BGE DEVICE, MODEL 21-001?

NAVIAID BGE DEVICE, MODEL 21-001 is a medical device that received FDA 510(k) clearance on 2006-08-15. The listed applicant is Smart Medical Systems , Ltd.. The 510(k) number is K060923.

When did NAVIAID BGE DEVICE, MODEL 21-001 receive FDA 510(k) clearance?

NAVIAID BGE DEVICE, MODEL 21-001 received FDA 510(k) clearance on 2006-08-15, under 510(k) number K060923.

Who is the listed applicant for NAVIAID BGE DEVICE, MODEL 21-001?

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

What is the FDA product code for NAVIAID BGE DEVICE, MODEL 21-001?

The FDA product code for NAVIAID BGE DEVICE, MODEL 21-001 is FDA.

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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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