The following data is part of a premarket notification filed by Analogic Corporation with the FDA for Sonic Window.
Device ID | K161342 |
510k Number | K161342 |
Device Name: | Sonic Window |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | ANALOGIC CORPORATION 8 CENTENNIAL DRIVE Peabody, MA 01960 |
Contact | Michael J. Doyle |
Correspondent | Michael J. Doyle ANALOGIC CORPORATION 8 CENTENNIAL DRIVE Peabody, MA 01960 |
Product Code | IYO |
Subsequent Product Code | ITX |
Subsequent Product Code | IYN |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-13 |
Decision Date | 2016-06-15 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SONIC WINDOW 87323149 5295007 Live/Registered |
Analogic Corporation 2017-02-03 |
SONIC WINDOW 78729215 3797621 Dead/Cancelled |
PocketSonics, Inc. 2005-10-07 |