The following data is part of a premarket notification filed by Deeplook Inc. with the FDA for Deeplook Precise.
Device ID | K202084 |
510k Number | K202084 |
Device Name: | DeepLook PRECISE |
Classification | System, Image Processing, Radiological |
Applicant | DeepLook Inc. 1220 Burton Street Silver Spring, MD 20910 |
Contact | Steven Schwadron |
Correspondent | Carl Alletto OTech Inc 8317 Belew Drive Mckinney, TX 75071 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-27 |
Decision Date | 2021-04-09 |