PACHYCAM
FDA 510(k) clearance K041841 · decided 2005-01-28
Clearance details
- K-number
- K041841
- Device name
- PACHYCAM
- Applicant
- Oculus Optikgerate GmbH
- Decision
- Substantially Equivalent
- Date received
- 2004-07-08
- Decision date
- 2005-01-28
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- MXK
- Device class
- 2
- Regulation number
- 886.1850
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Wetzla-Dutenhofen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.