The following data is part of a premarket notification filed by Caption Health with the FDA for Caption Guidance.
| Device ID | K201992 |
| 510k Number | K201992 |
| 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 | 2020-07-17 |
| Decision Date | 2020-09-18 |
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 |