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FDA 510(k)

CARA

K-Number: K110869 · 2011-07-14

ApplicantDiagnos, Inc.
Decision Date2011-07-14
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARA is the device name listed in this FDA 510(k) record. The listed applicant is Diagnos, Inc.. It received FDA 510(k) clearance on 2011-07-14 under 510(k) number K110869. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARA?

CARA is a medical device that received FDA 510(k) clearance on 2011-07-14. The listed applicant is Diagnos, Inc.. The 510(k) number is K110869.

When did CARA receive FDA 510(k) clearance?

CARA received FDA 510(k) clearance on 2011-07-14, under 510(k) number K110869.

Who is the listed applicant for CARA?

The FDA 510(k) record lists Diagnos, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARA?

The FDA product code for CARA is NFJ.

Related Devices (Code: NFJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260694ZEISS CLINIC 360Carl Zeiss Meditec, AGK253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA OyK234076iCare ALTIUS CWCentervue S.P.A.K232828IMAGEnet6 Ophthalmic Data SystemTopcon CorporationK232944CALLISTO eyeCarl Zeiss Meditec, AGK232555HarmonyTopcon Healthcare Solutions

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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