510(k) K945541
K945541 is an FDA 510(k) premarket notification submitted by Rudolf Riester GmbH & Co. KG for the device "SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE". The FDA issued a decision of Substantially Equivalent on May 8, 1995. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Rudolf Riester GmbH & Co. KG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1995
- Date Received
- November 10, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Manual
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type