FDA 510(k)

RHA2020

K-Number: K111531 · 2011-07-08

Decision Date2011-07-08

Product CodeHLI

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

RHA2020 is the device name listed in this FDA 510(k) record. The listed applicant is Annidis Health Systems Corp.. It received FDA 510(k) clearance on 2011-07-08 under 510(k) number K111531. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHA2020?

RHA2020 is a medical device that received FDA 510(k) clearance on 2011-07-08. The listed applicant is Annidis Health Systems Corp.. The 510(k) number is K111531.

When did RHA2020 receive FDA 510(k) clearance?

RHA2020 received FDA 510(k) clearance on 2011-07-08, under 510(k) number K111531.

Who is the listed applicant for RHA2020?

The FDA 510(k) record lists Annidis Health Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RHA2020?

The FDA product code for RHA2020 is HLI.

Related Devices (Code: HLI)

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.

K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KG K121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K103266ISTANDOptovue, Inc.

Official Source

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