Second Opinion
Analyzer, Medical Image
Pearl Inc.
The following data is part of a premarket notification filed by Pearl Inc. with the FDA for Second Opinion.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003567920 | K210365 | 000 |
Trademark Results [Second Opinion]
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