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FDA 510(k)

OPTIDOS

K-Number: K010705 · 2003-03-11

ApplicantPtw-New York Corp.
Decision Date2003-03-11
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPTIDOS is the device name listed in this FDA 510(k) record. The listed applicant is Ptw-New York Corp.. It received FDA 510(k) clearance on 2003-03-11 under 510(k) number K010705. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIDOS?

OPTIDOS is a medical device that received FDA 510(k) clearance on 2003-03-11. The listed applicant is Ptw-New York Corp.. The 510(k) number is K010705.

When did OPTIDOS receive FDA 510(k) clearance?

OPTIDOS received FDA 510(k) clearance on 2003-03-11, under 510(k) number K010705.

Who is the listed applicant for OPTIDOS?

The FDA 510(k) record lists Ptw-New York Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIDOS?

The FDA product code for OPTIDOS is KXK.

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Other records listing Ptw-New York Corp. as applicant

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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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