510(k) K851263
K851263 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP". The FDA issued a decision of Substantially Equivalent on May 1, 1985. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. American Medical Optics has 16 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 1985
- Date Received
- Mar 28, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Ophthalmoscope, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type
- 510(k) Exempt