Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K163510 |
Device Name |
Poseidon Ultrasound System |
Applicant |
BUTTERFLY NETWORK, INC. |
530 OLD WHITFIELD STREET |
guilford,
CT
06437
|
|
Applicant Contact |
brian sawin |
Correspondent |
BUTTERFLY NETWORK, INC. |
530 OLD WHITFIELD STREET |
guilford,
CT
06437
|
|
Correspondent Contact |
brian sawin |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/15/2016 |
Decision Date | 09/06/2017 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|