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FDA 510(k)

PANORET, MODEL PNM 60

K-Number: K040325 · 2004-03-08

ApplicantMedibell Medical Vision Technologies , Ltd.
Decision Date2004-03-08
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PANORET, MODEL PNM 60 is the device name listed in this FDA 510(k) record. The listed applicant is Medibell Medical Vision Technologies , Ltd.. It received FDA 510(k) clearance on 2004-03-08 under 510(k) number K040325. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANORET, MODEL PNM 60?

PANORET, MODEL PNM 60 is a medical device that received FDA 510(k) clearance on 2004-03-08. The listed applicant is Medibell Medical Vision Technologies , Ltd.. The 510(k) number is K040325.

When did PANORET, MODEL PNM 60 receive FDA 510(k) clearance?

PANORET, MODEL PNM 60 received FDA 510(k) clearance on 2004-03-08, under 510(k) number K040325.

Who is the listed applicant for PANORET, MODEL PNM 60?

The FDA 510(k) record lists Medibell Medical Vision Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANORET, MODEL PNM 60?

The FDA product code for PANORET, MODEL PNM 60 is HKI.

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Official Source

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