Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K220068
Device Name Butterfly iQ/iQ+ Ultrasound System
Applicant
Butterfly Network, Inc.
530 Old Whitfield Street
Guilford,  CT  06437
Applicant Contact Brian Sawin
Correspondent
Butterfly Network, Inc.
1600 District Ave
Burlington,  MA  01803
Correspondent Contact Lynda Ikejimba
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN   QIH  
Date Received01/10/2022
Decision Date 03/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-