510(k) K070534
K070534 is an FDA 510(k) premarket notification submitted by Reichert, Inc. for the device "MODIFICATION TO: OCU-FILM TIP COVER". The FDA issued a decision of Substantially Equivalent on March 27, 2007. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Reichert, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2007
- Date Received
- February 26, 2007
- Clearance Type
- Special
- 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