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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 the device name listed in this FDA 510(k) record. The listed applicant is Nview Medical, Inc.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) 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. The listed applicant is Nview Medical, Inc.. The 510(k) number is K190064.

When did nView system 1 receive FDA 510(k) clearance?

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

Who is the listed applicant for nView system 1?

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

What is the FDA product code for nView system 1?

The FDA product code for nView system 1 is OWB.

Other records listing Nview Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221344nView s1 with nav optionK211064nView s1 with nav option

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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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