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FDA 510(k)

SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM

K-Number: K091515 · 2009-07-09

ApplicantNovadaq Technologies, Inc.
Decision Date2009-07-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies, Inc.. It received FDA 510(k) clearance on 2009-07-09 under 510(k) number K091515. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM?

SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-09. The listed applicant is Novadaq Technologies, Inc.. The 510(k) number is K091515.

When did SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM receive FDA 510(k) clearance?

SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM received FDA 510(k) clearance on 2009-07-09, under 510(k) number K091515.

Who is the listed applicant for SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM?

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

What is the FDA product code for SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM?

The FDA product code for SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM is GCJ.

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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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