The following data is part of a premarket notification filed by Caption Health with the FDA for Caption Guidance.
Device ID | K200755 |
510k Number | K200755 |
Device Name: | Caption Guidance |
Classification | Image Acquisition And/or Optimization Guided By Artificial Intelligence |
Applicant | Caption Health 2000 Sierra Point Pkwy Brisbane, CA 94005 |
Contact | Sam Surette |
Correspondent | Sam Surette Caption Health 2000 Sierra Point Pkwy Brisbane, CA 94005 |
Product Code | QJU |
CFR Regulation Number | 892.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-23 |
Decision Date | 2020-04-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CAPTION GUIDANCE 88574778 not registered Live/Pending |
Bay Labs, Inc. 2019-08-12 |
CAPTION GUIDANCE 88574775 not registered Live/Pending |
Bay Labs, Inc. 2019-08-12 |