510(k) K923877
K923877 is an FDA 510(k) premarket notification submitted by Oasis Medical, Inc. for the device "TONOSHIELD TONOMETER SHIELD". The FDA issued a decision of Substantially Equivalent on September 30, 1992. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Oasis Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1992
- Date Received
- August 3, 1992
- 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