The following data is part of a premarket notification filed by Nines, Inc. with the FDA for Ninesmeasure.
Device ID | K202990 |
510k Number | K202990 |
Device Name: | NinesMeasure |
Classification | System, Image Processing, Radiological |
Applicant | Nines, Inc. 329 Alma St. Palo Alto, CA 94301 |
Contact | Russell Stewart |
Correspondent | John J. Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-30 |
Decision Date | 2021-02-25 |