510(k) K211355
K211355 is an FDA 510(k) premarket notification submitted by Icare Finland OY for the device "iCare HOME2". The FDA issued a decision of Substantially Equivalent on January 25, 2022. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Icare Finland OY has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2022
- Date Received
- May 3, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Manual
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type