510(k) K950793
K950793 is an FDA 510(k) premarket notification submitted by Neitz Instruments Company, Ltd. for the device "SPOT RETINOSCOPE RX-3SP". The FDA issued a decision of Substantially Equivalent on Mar 28, 1995. The device falls under product code HKM (Retinoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1780. Neitz Instruments Company, Ltd. has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 28, 1995
- Date Received
- Feb 21, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retinoscope, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.1780
- Review Panel
- OP
- Submission Type
- 510(k) Exempt