510(k) K232143
K232143 is an FDA 510(k) premarket notification submitted by Huvitz Co., Ltd. for the device "Applanation Tonometer HT-5000". The FDA issued a decision of Substantially Equivalent on October 23, 2023. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Huvitz Co., Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 2023
- Date Received
- July 19, 2023
- 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