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FDA 510(k)

nView system 1

K-Number: K190064 · 2019-07-08

ApplicantNview Medical, Inc.
Decision Date2019-07-08
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

nView system 1 is a medical device manufactured by Nview Medical, Inc.. It received FDA 510(k) clearance on 2019-07-08 under approval number K190064. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the nView system 1?

nView system 1 is a medical device that received FDA 510(k) clearance on 2019-07-08. It is manufactured by Nview Medical, Inc.. The 510(k) number is K190064.

When was nView system 1 approved by the FDA?

nView system 1 received FDA 510(k) clearance on 2019-07-08, under approval number K190064.

What company makes nView system 1?

nView system 1 is manufactured by Nview Medical, Inc..

What is the FDA product code for nView system 1?

The FDA product code for nView system 1 is OWB.

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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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