The following data is part of a premarket notification filed by Metritrack, Inc. with the FDA for Breast Volume Navigator (bvn) Model G-2000.
| Device ID | K211098 |
| 510k Number | K211098 |
| Device Name: | Breast Volume Navigator (BVN) Model G-2000 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MetriTrack, Inc. 4415 W. Harrison Street Suite 243 Hillside, IL 60162 |
| Contact | Mirela Wohlford |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-04-13 |
| Decision Date | 2021-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08636860003008 | K211098 | 000 |
| 00863686000302 | K211098 | 000 |