CIRRUS HD-OCT— 510(k) K181534
Substantially EquivalentCarl Zeiss Meditec, Inc.
FDA 510(k) clearance K181534 for CIRRUS HD-OCT, Substantially Equivalent on 2019-02-15. 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 K181534
K-number listed on FDA's recall record- Z-0723-2022 — CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
- Z-2227-2021 — Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181534.
Data sourced from openFDA. This site is unofficial and independent of the FDA.