FDA 510(k)

WIRELESS IMAGE TRANSMITTER UNIT

K-Number: K120278 · 2012-08-10

Decision Date2012-08-10

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

WIRELESS IMAGE TRANSMITTER UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2012-08-10 under 510(k) number K120278. 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 WIRELESS IMAGE TRANSMITTER UNIT?

WIRELESS IMAGE TRANSMITTER UNIT is a medical device that received FDA 510(k) clearance on 2012-08-10. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K120278.

When did WIRELESS IMAGE TRANSMITTER UNIT receive FDA 510(k) clearance?

WIRELESS IMAGE TRANSMITTER UNIT received FDA 510(k) clearance on 2012-08-10, under 510(k) number K120278.

Who is the listed applicant for WIRELESS IMAGE TRANSMITTER UNIT?

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

What is the FDA product code for WIRELESS IMAGE TRANSMITTER UNIT?

The FDA product code for WIRELESS IMAGE TRANSMITTER UNIT 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.