510(k) K132323
K132323 is an FDA 510(k) premarket notification submitted by Nidek Co., Ltd. for the device "RS-3000 ADVANCE". The FDA issued a decision of Substantially Equivalent on February 19, 2014. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Nidek Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 2014
- Date Received
- July 25, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tomography, Optical Coherence
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.