Breast Volume Navigator (BVN) Model G-2000
FDA 510(k) K211098 · Metritrack, Inc.
510(k) numberK211098
Submission
- Device name
- Breast Volume Navigator (BVN) Model G-2000
- Applicant
- Metritrack, Inc.
Hillside, IL, US - Received
- April 13, 2021
- Decision date
- May 26, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Breast Volume Navigator (BVN) Model G-2000 cleared by the FDA?
Breast Volume Navigator (BVN) Model G-2000 (K211098) received a 510(k) decision of Substantially Equivalent on May 26, 2021, 43 days after the submission was received.
What is the product code of K211098?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.