The following data is part of a premarket notification filed by Caption Health with the FDA for Caption Interpretation Automated Ejection Fraction Software.
| Device ID | K210747 |
| 510k Number | K210747 |
| Device Name: | Caption Interpretation Automated Ejection Fraction Software |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Caption Health 2000 Sierra Point Pkwy Brisbane, CA 94005 |
| Contact | Sam Surette |
| Correspondent | Savannah Hari Manatt, Phelps & Phillips, LLP 1 Embarcadero Center, 30th Floor San Francisco, CA 94111 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-12 |
| Decision Date | 2022-01-19 |