510(k) K181534 ยท OBO Tomography, Optical Coherence
CIRRUS HD-OCT
| Applicant | Carl Zeiss Meditec, Inc., Dublin CA, US |
| Decision | Substantially Equivalent, Feb 15, 2019 |
| Received | Jun 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181534
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2022 | Carl Zeiss Meditec, Inc. CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex Open, Classified |
OBO | None listed |
| Jul 8, 2021 | Carl Zeiss Meditec, Inc. Chassis Label - "CIRRUS HD-OCT Rx-Only"
Product Label Exterior RX - "CIRRUS HD-OCT Model 6000" Open, Classified |
OBO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.