510(k) DEN140017
- Device
- SENSIMED TRIGGERFISH
- Applicant
- Sensimed AG
- 510(k) number
- DEN140017
- Product code
- PLZ
- Decision
- Unknown (DENG)
- Decision date
- 2016-03-04
- Date received
- 2014-05-06
- Regulation
- 886.1925
- Classification name
- Ocular Pattern Recorder
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Marcy Moore
- Address
- 16 Appleton St. Waltham MA US 02453 02453
FDA Registration Numbers#
- 3008727434
Source Documents#
510(k) summary PDF not indicated by FDA