The following data is part of a premarket notification filed by Neurologica Corporation, A Subsidiary Of Samsung Electronics with the FDA for Bodytom Elite.
Device ID | K170238 |
510k Number | K170238 |
Device Name: | BodyTom Elite |
Classification | System, X-ray, Tomography, Computed |
Applicant | NeuroLogica Corporation, A Subsidiary Of Samsung Electronics 14 Electronics Avenue Danvers, MA 01923 |
Contact | Ninad Gujar |
Correspondent | Ninad Gujar NeuroLogica Corporation, A Subsidiary Of Samsung Electronics 14 Electronics Avenue Danvers, MA 01923 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-26 |
Decision Date | 2017-06-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10815411020311 | K170238 | 000 |
10815411020274 | K170238 | 000 |
10815411020823 | K170238 | 000 |
10815411020816 | K170238 | 000 |
10815411020809 | K170238 | 000 |