The following data is part of a premarket notification filed by Analogic Corporation with the FDA for Sonic Window.
Device ID | K140126 |
510k Number | K140126 |
Device Name: | SONIC WINDOW |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | ANALOGIC CORPORATION 8 CENTENNIAL DRIVE Peabody, MA 01960 |
Contact | Albert C Cefalo |
Correspondent | Albert C Cefalo ANALOGIC CORPORATION 8 CENTENNIAL DRIVE Peabody, MA 01960 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-16 |
Decision Date | 2014-03-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
90814277020127 | K140126 | 000 |
90814277020028 | K140126 | 000 |
90814277020011 | K140126 | 000 |
90814277020004 | K140126 | 000 |
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 |