510(k) K182491
K182491 is an FDA 510(k) premarket notification submitted by Takagi Seiko Co., Ltd. for the device "Applanation tonometer AT-2". The FDA issued a decision of Substantially Equivalent on December 10, 2018. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Takagi Seiko Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 2018
- Date Received
- September 11, 2018
- 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