510(k) K864369
K864369 is an FDA 510(k) premarket notification submitted by Heidelberg Instruments for the device "LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER". The FDA issued a decision of Substantially Equivalent on December 15, 1986. The device falls under product code HJB (Instrument, Measuring, Corneal Radius), a Class I device regulated under 21 CFR 886.1450.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1986
- Date Received
- November 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Measuring, Corneal Radius
- Device Class
- Class I
- Regulation Number
- 886.1450
- Review Panel
- OP
- Submission Type