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FDA 510(k)

NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE

K-Number: K110291 · 2011-06-17

ApplicantSmart Medical Systems , Ltd.
Decision Date2011-06-17
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE 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 2011-06-17 under 510(k) number K110291. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE?

NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE is a medical device that received FDA 510(k) clearance on 2011-06-17. The listed applicant is Smart Medical Systems , Ltd.. The 510(k) number is K110291.

When did NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE receive FDA 510(k) clearance?

NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE received FDA 510(k) clearance on 2011-06-17, under 510(k) number K110291.

Who is the listed applicant for NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE?

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 ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE?

The FDA product code for NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE is ODC.

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Other records listing Smart Medical Systems , Ltd. as applicant

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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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