510(k) K852774
K852774 is an FDA 510(k) premarket notification submitted by Oculab, Inc. for the device "OCULAB TONOPEN". The FDA issued a decision of Substantially Equivalent on August 20, 1985. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Oculab, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1985
- Date Received
- July 1, 1985
- 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