510(k) K162636
K162636 is an FDA 510(k) premarket notification submitted by Takagi Seiko Co., Ltd. for the device "Marco Ultra M3, Marco Ultra M4". The FDA issued a decision of Substantially Equivalent on April 14, 2017. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Takagi Seiko Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2017
- Date Received
- September 21, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biomicroscope, Slit-Lamp, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type