510(k) K203500
K203500 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) for the device "RetCam Envision". The FDA issued a decision of Substantially Equivalent on April 13, 2021. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2021
- Date Received
- November 30, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Ophthalmic, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type