510(k) K030393
K030393 is an FDA 510(k) premarket notification submitted by Haag-Streit Holding AG for the device "OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER". The FDA issued a decision of Substantially Equivalent on September 25, 2003. The device falls under product code MXK (Device, Analysis, Anterior Segment), a Class II device regulated under 21 CFR 886.1850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 2003
- Date Received
- February 5, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Analysis, Anterior Segment
- Device Class
- Class II
- Regulation Number
- 886.1850
- Review Panel
- OP
- Submission Type