FDA 510(k)

Breast Volume Navigator (BVN) Model G-2000

K-Number: K211098 · 2021-05-26

Decision Date2021-05-26

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Breast Volume Navigator (BVN) Model G-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Metritrack, Inc.. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K211098. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Breast Volume Navigator (BVN) Model G-2000?

Breast Volume Navigator (BVN) Model G-2000 is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Metritrack, Inc.. The 510(k) number is K211098.

When did Breast Volume Navigator (BVN) Model G-2000 receive FDA 510(k) clearance?

Breast Volume Navigator (BVN) Model G-2000 received FDA 510(k) clearance on 2021-05-26, under 510(k) number K211098.

Who is the listed applicant for Breast Volume Navigator (BVN) Model G-2000?

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

What is the FDA product code for Breast Volume Navigator (BVN) Model G-2000?

The FDA product code for Breast Volume Navigator (BVN) Model G-2000 is IYO.

Related Devices (Code: IYO)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.