The following data is part of a premarket notification filed by Esaote S.p.a. with the FDA for S-scan.
Device ID | K161238 |
510k Number | K161238 |
Device Name: | S-scan |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Esaote S.p.A. Via Siffredi 58 Genovo, IT 16153 |
Contact | Donatella Ragghianti |
Correspondent | Allison Scott Navigant Consulting, Inc 9001 Wesleyan Road, Suite 200 Indianapolis, IN 46268 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-05-02 |
Decision Date | 2016-07-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
S-SCAN 79147952 4718603 Live/Registered |
Stjernfjädrar AB 2014-04-16 |