The following data is part of a premarket notification filed by Butterfly Network, Inc. with the FDA for Auto 3d Bladder Volume Tool.
| Device ID | K200980 |
| 510k Number | K200980 |
| Device Name: | Auto 3D Bladder Volume Tool |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Butterfly Network, Inc. 530 Old Whitfield Street Guilford, CT 06437 |
| Contact | Brian Sawin |
| Correspondent | Brian Sawin Butterfly Network, Inc. 530 Old Whitfield Street Guilford, CT 06437 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-14 |
| Decision Date | 2020-06-11 |