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FDA 510(k)

PDT DOSECALCULATOR, MODEL 80000

K-Number: K000418 · 2000-10-24

ApplicantRetinalabs.Com
Decision Date2000-10-24
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PDT DOSECALCULATOR, MODEL 80000 is the device name listed in this FDA 510(k) record. The listed applicant is Retinalabs.Com. It received FDA 510(k) clearance on 2000-10-24 under 510(k) number K000418. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDT DOSECALCULATOR, MODEL 80000?

PDT DOSECALCULATOR, MODEL 80000 is a medical device that received FDA 510(k) clearance on 2000-10-24. The listed applicant is Retinalabs.Com. The 510(k) number is K000418.

When did PDT DOSECALCULATOR, MODEL 80000 receive FDA 510(k) clearance?

PDT DOSECALCULATOR, MODEL 80000 received FDA 510(k) clearance on 2000-10-24, under 510(k) number K000418.

Who is the listed applicant for PDT DOSECALCULATOR, MODEL 80000?

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

What is the FDA product code for PDT DOSECALCULATOR, MODEL 80000?

The FDA product code for PDT DOSECALCULATOR, MODEL 80000 is NDC.

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Other records listing Retinalabs.Com 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.

K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESK000420SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003K000416TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

Related Devices (Code: NDC)

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

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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