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FDA 510(k)

AAIO-7, AAIO WIRLESS

K-Number: K110205 · 2011-02-09

ApplicantAppasamy Associates
Decision Date2011-02-09
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AAIO-7, AAIO WIRLESS is the device name listed in this FDA 510(k) record. The listed applicant is Appasamy Associates. It received FDA 510(k) clearance on 2011-02-09 under 510(k) number K110205. 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 AAIO-7, AAIO WIRLESS?

AAIO-7, AAIO WIRLESS is a medical device that received FDA 510(k) clearance on 2011-02-09. The listed applicant is Appasamy Associates. The 510(k) number is K110205.

When did AAIO-7, AAIO WIRLESS receive FDA 510(k) clearance?

AAIO-7, AAIO WIRLESS received FDA 510(k) clearance on 2011-02-09, under 510(k) number K110205.

Who is the listed applicant for AAIO-7, AAIO WIRLESS?

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

What is the FDA product code for AAIO-7, AAIO WIRLESS?

The FDA product code for AAIO-7, AAIO WIRLESS is HLI.

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Other records listing Appasamy Associates as applicant

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.

K082031APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES

Related Devices (Code: HLI)

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K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KGK121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems Corp.

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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