510(k) K964338
K964338 is an FDA 510(k) premarket notification submitted by Rudolf Riester GmbH & Co. KG for the device "RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT". The FDA issued a decision of Substantially Equivalent on Jan 9, 1997. The device falls under product code HKM (Retinoscope, Battery-Powered), a Class I device regulated under 21 CFR 886.1780. Rudolf Riester GmbH & Co. KG has 29 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 9, 1997
- Date Received
- Oct 31, 1996
- 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