The following data is part of a premarket notification filed by Butterfly Network, Inc. with the FDA for Butterfly Iq Ultrasound System.
| Device ID | K202406 |
| 510k Number | K202406 |
| Device Name: | Butterfly IQ Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Butterfly Network, Inc. 530 Old Whitfield Street Guilford, CT 06437 |
| Contact | Brian Sawin |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2020-09-16 |