FDA 510(k)

Discovery NM 750b Bopsy

K-Number: K160933 · 2016-11-18

Decision Date2016-11-18

Product CodeIYX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Discovery NM 750b Bopsy is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K160933. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Discovery NM 750b Bopsy?

Discovery NM 750b Bopsy is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is GE Healthcare. The 510(k) number is K160933.

When did Discovery NM 750b Bopsy receive FDA 510(k) clearance?

Discovery NM 750b Bopsy received FDA 510(k) clearance on 2016-11-18, under 510(k) number K160933.

Who is the listed applicant for Discovery NM 750b Bopsy?

The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Discovery NM 750b Bopsy?

The FDA product code for Discovery NM 750b Bopsy is IYX.

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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.