510(k) K232273
K232273 is an FDA 510(k) premarket notification submitted by Retmap, Inc. for the device "RM Electrode (RMH 23-01)". The FDA issued a decision of Substantially Equivalent on December 7, 2023. The device falls under product code HLZ (Electrode, Corneal), a Class II device regulated under 21 CFR 886.1220. Retmap, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 2023
- Date Received
- July 31, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Corneal
- Device Class
- Class II
- Regulation Number
- 886.1220
- Review Panel
- OP
- Submission Type