510(k) K802351
K802351 is an FDA 510(k) premarket notification submitted by Minami, Tomine & Lew for the device "F110 PHOTO BINOCULAR OPHTHALMOSCOPE". The FDA issued a decision of Substantially Equivalent on December 17, 1980. The device falls under product code HLG (Pupillometer, Ac-Powered), a Class I device regulated under 21 CFR 886.1700.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1980
- Date Received
- September 25, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pupillometer, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.1700
- Review Panel
- OP
- Submission Type