510(k) K942715
K942715 is an FDA 510(k) premarket notification submitted by Neitz Instruments Company, Ltd. for the device "NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC". The FDA issued a decision of Substantially Equivalent on Aug 5, 1994. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Neitz Instruments Company, Ltd. has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 5, 1994
- Date Received
- Jun 9, 1994
- 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