FDA 510(k)

PVS BASIC 2; EPIC 2

K-Number: K013310 · 2002-04-25

Decision Date2002-04-25

Product CodeHQD

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

PVS BASIC 2; EPIC 2 is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Vision Sciences. It received FDA 510(k) clearance on 2002-04-25 under 510(k) number K013310. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVS BASIC 2; EPIC 2?

PVS BASIC 2; EPIC 2 is a medical device that received FDA 510(k) clearance on 2002-04-25. The listed applicant is Paragon Vision Sciences. The 510(k) number is K013310.

When did PVS BASIC 2; EPIC 2 receive FDA 510(k) clearance?

PVS BASIC 2; EPIC 2 received FDA 510(k) clearance on 2002-04-25, under 510(k) number K013310.

Who is the listed applicant for PVS BASIC 2; EPIC 2?

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

What is the FDA product code for PVS BASIC 2; EPIC 2?

The FDA product code for PVS BASIC 2; EPIC 2 is HQD.

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Related Devices (Code: HQD)

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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.