The following data is part of a premarket notification filed by Pearl Inc. with the FDA for Second Opinion.
Device ID | K210365 |
510k Number | K210365 |
Device Name: | Second Opinion |
Classification | Analyzer, Medical Image |
Applicant | Pearl Inc. 2515 Benedict Canyon Drive Beverly Hills, CA 90210 |
Contact | Bill Birdsall |
Correspondent | Zvi Ladin Boston MedTech Advisors 990 Washington Street Suite 204 Dedham, MA 02026 -6717 |
Product Code | MYN |
CFR Regulation Number | 892.2070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-08 |
Decision Date | 2022-03-04 |