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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850027593081 | K200980 | 000 |
00850027593111 | K200980 | 000 |