The following data is part of a premarket notification filed by Butterfly Network, Inc. with the FDA for Poseidon Ultrasound System.
| Device ID | K163510 |
| 510k Number | K163510 |
| Device Name: | Poseidon Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, 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 | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-15 |
| Decision Date | 2017-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866646000206 | K163510 | 000 |
| 00850027593012 | K163510 | 000 |
| 00866646000275 | K163510 | 000 |
| 00866646000213 | K163510 | 000 |
| 00866646000220 | K163510 | 000 |
| 00866646000237 | K163510 | 000 |
| 00866646000244 | K163510 | 000 |
| 00866646000251 | K163510 | 000 |
| 00866646000268 | K163510 | 000 |
| 00866646000282 | K163510 | 000 |
| 00866646000299 | K163510 | 000 |
| 00866646000305 | K163510 | 000 |
| 00850027593005 | K163510 | 000 |