510(k) K950789
K950789 is an FDA 510(k) premarket notification submitted by Neitz Instruments Company, Ltd. for the device "STREAK RETINOSCOPE RX-1". The FDA issued a decision of Substantially Equivalent on March 28, 1995. The device falls under product code HKL (Retinoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1780. Neitz Instruments Company, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1995
- Date Received
- February 21, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retinoscope, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1780
- Review Panel
- OP
- Submission Type