510(k) K934880
K934880 is an FDA 510(k) premarket notification submitted by Medical Technology and Innovations, Inc. for the device "MTI PHOTOSCREENER". The FDA issued a decision of Substantially Equivalent on April 6, 1994. The device falls under product code MMF (Photorefractor), a Class II device regulated under 21 CFR 886.1120. Medical Technology and Innovations, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1994
- Date Received
- October 12, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photorefractor
- Device Class
- Class II
- Regulation Number
- 886.1120
- Review Panel
- OP
- Submission Type