510(k) K832996
K832996 is an FDA 510(k) premarket notification submitted by Miami Eye Technology, Inc. for the device "SURGICAL IOP MONITOR". The FDA issued a decision of Substantially Equivalent on November 28, 1983. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Miami Eye Technology, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 1983
- Date Received
- September 2, 1983
- 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