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FDA 510(k)

IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP

K-Number: K071299 · 2007-08-31

ApplicantDigital Healthcare, Ltd.
Decision Date2007-08-31
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP is the device name listed in this FDA 510(k) record. The listed applicant is Digital Healthcare, Ltd.. It received FDA 510(k) clearance on 2007-08-31 under 510(k) number K071299. 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 IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP?

IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP is a medical device that received FDA 510(k) clearance on 2007-08-31. The listed applicant is Digital Healthcare, Ltd.. The 510(k) number is K071299.

When did IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP receive FDA 510(k) clearance?

IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP received FDA 510(k) clearance on 2007-08-31, under 510(k) number K071299.

Who is the listed applicant for IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP?

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

What is the FDA product code for IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP?

The FDA product code for IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP is NFJ.

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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.

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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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