510(k) K071755
K071755 is an FDA 510(k) premarket notification submitted by Falck Medical, Inc. for the device "FALCK APPLANATION TONOMETER (FAT2)". The FDA issued a decision of Substantially Equivalent on June 3, 2008. The device falls under product code HKY (Tonometer, Manual), a Class II device regulated under 21 CFR 886.1930. Falck Medical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2008
- Date Received
- June 28, 2007
- 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