The following data is part of a premarket notification filed by Sentiar, Inc with the FDA for Sentep.
Device ID | K192890 |
510k Number | K192890 |
Device Name: | SentEP |
Classification | System, Image Processing, Radiological |
Applicant | SentiAR, Inc 212 Kingshighway Blvd., Suite 115 Mailbox 28 St. Louis, MO 63108 |
Contact | Berk Tas |
Correspondent | Berk Tas SentiAR, Inc 212 Kingshighway Blvd., Suite 115 Mailbox 28 St. Louis, MO 63108 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-10-10 |
Decision Date | 2020-09-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850013331031 | K192890 | 000 |
00850013331024 | K192890 | 000 |
00850013331017 | K192890 | 000 |