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FDA 510(k)

OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5

K-Number: K053044 · 2006-01-24

ApplicantOpto Global, Inc.
Decision Date2006-01-24
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 is the device name listed in this FDA 510(k) record. The listed applicant is Opto Global, Inc.. It received FDA 510(k) clearance on 2006-01-24 under 510(k) number K053044. 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 OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5?

OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 is a medical device that received FDA 510(k) clearance on 2006-01-24. The listed applicant is Opto Global, Inc.. The 510(k) number is K053044.

When did OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 receive FDA 510(k) clearance?

OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 received FDA 510(k) clearance on 2006-01-24, under 510(k) number K053044.

Who is the listed applicant for OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5?

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

What is the FDA product code for OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5?

The FDA product code for OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 is HKI.

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Related Devices (Code: HKI)

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.

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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.

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