FDA 510(k)

POD PAC-20M

K-Number: K030610 · 2003-03-21

ApplicantPortable Ophthalmic Devices, Inc.

Decision Date2003-03-21

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

POD PAC-20M is the device name listed in this FDA 510(k) record. The listed applicant is Portable Ophthalmic Devices, Inc.. It received FDA 510(k) clearance on 2003-03-21 under 510(k) number K030610. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POD PAC-20M?

POD PAC-20M is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Portable Ophthalmic Devices, Inc.. The 510(k) number is K030610.

When did POD PAC-20M receive FDA 510(k) clearance?

POD PAC-20M received FDA 510(k) clearance on 2003-03-21, under 510(k) number K030610.

Who is the listed applicant for POD PAC-20M?

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

What is the FDA product code for POD PAC-20M?

The FDA product code for POD PAC-20M is IYO.

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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.