510(k) K990869
K990869 is an FDA 510(k) premarket notification submitted by Leica Microsystems, Inc. for the device "LEICA AT550". The FDA issued a decision of Substantially Equivalent on June 7, 1999. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Leica Microsystems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 1999
- Date Received
- March 16, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1930
- Review Panel
- OP
- Submission Type