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 |