510(k) K840840
K840840 is an FDA 510(k) premarket notification submitted by Electro Optical Instruments for the device "GENERATED RETINAL REFLEX IMAGERY SYS". The FDA issued a decision of Substantially Equivalent on July 12, 1984. The device falls under product code HKM (Retinoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1780.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1984
- Date Received
- February 24, 1984
- 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