510(k) K093521
K093521 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, Inc. for the device "GDXPRO". The FDA issued a decision of Substantially Equivalent on November 25, 2009. The device falls under product code MYC (Ophthalmoscope, Laser, Scanning), a Class II device regulated under 21 CFR 886.1570. Carl Zeiss Meditec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2009
- Date Received
- November 13, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Ophthalmoscope, Laser, Scanning
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type