PLEX Elite 9000 SS-OCT— 510(k) K161194
Substantially EquivalentCarl Zeiss Meditec, Inc.
FDA 510(k) clearance K161194 for PLEX Elite 9000 SS-OCT, Substantially Equivalent on 2016-10-26. Applicant: Carl Zeiss Meditec, Inc.. Device class: 2.
Clearance details
- Applicant
- Carl Zeiss Meditec, Inc.
- Product code
- Code OBO
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dublin, CA, US
Recent devices under product code OBO
view allMore clearances from Carl Zeiss Meditec, Inc.
view allRecalls naming K161194
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161194.
Data sourced from openFDA. This site is unofficial and independent of the FDA.