510(k) K181444
- Device
- CLARUS
- Applicant
- Carl Zeiss Meditec, Inc.
- 510(k) number
- K181444
- Product code
- QER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-01-10
- Date received
- 2018-06-01
- Regulation
- 886.1120
- Classification name
- Camera, Ophthalmic, Slit-scanning
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Saurabh Jamkhindikar
- Address
- 5160 Hacienda Dr. Dublin CA US 94568 94568
FDA Registration Numbers#
- 2918630
- 3003589956
Source Documents#
Other 510(k) Records For Product Code QER #
Legacy Summary#
summary
FDA Review#
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