RetCam 3; RetCam Shuttle; RetCam Portable— 510(k) K182263

Name: FDA 510(k) clearance K182263
Creator: U.S. Food and Drug Administration
Published: 2018-09-07

Substantially Equivalent

Natus Medical Incorporated

FDA 510(k) clearance K182263 for RetCam 3; RetCam Shuttle; RetCam Portable, Substantially Equivalent on 2018-09-07. Applicant: Natus Medical Incorporated. Device class: 2.

Clearance details

Device name as filed: RetCam 3 ; RetCam Shuttle ; RetCam Portable
Applicant: Natus Medical Incorporated
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2018-08-21
Decision date: 2018-09-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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