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FDA 510(k)

RetCam 3 ; RetCam Shuttle ; RetCam Portable

K-Number: K182263 · 2018-09-07

ApplicantNatus Medical Incorporated
Decision Date2018-09-07
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RetCam 3 ; RetCam Shuttle ; RetCam Portable is a medical device manufactured by Natus Medical Incorporated. It received FDA 510(k) clearance on 2018-09-07 under approval number K182263. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RetCam 3 ; RetCam Shuttle ; RetCam Portable?

RetCam 3 ; RetCam Shuttle ; RetCam Portable is a medical device that received FDA 510(k) clearance on 2018-09-07. It is manufactured by Natus Medical Incorporated. The 510(k) number is K182263.

When was RetCam 3 ; RetCam Shuttle ; RetCam Portable approved by the FDA?

RetCam 3 ; RetCam Shuttle ; RetCam Portable received FDA 510(k) clearance on 2018-09-07, under approval number K182263.

What company makes RetCam 3 ; RetCam Shuttle ; RetCam Portable?

RetCam 3 ; RetCam Shuttle ; RetCam Portable is manufactured by Natus Medical Incorporated.

What is the FDA product code for RetCam 3 ; RetCam Shuttle ; RetCam Portable?

The FDA product code for RetCam 3 ; RetCam Shuttle ; RetCam Portable is HKI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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