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FDA 510(k)

nView s1 with nav option

K-Number: K211064 · 2021-10-29

ApplicantNview Medical
Decision Date2021-10-29
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

nView s1 with nav option is the device name listed in this FDA 510(k) record. The listed applicant is Nview Medical. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K211064. 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 s1 with nav option?

nView s1 with nav option is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Nview Medical. The 510(k) number is K211064.

When did nView s1 with nav option receive FDA 510(k) clearance?

nView s1 with nav option received FDA 510(k) clearance on 2021-10-29, under 510(k) number K211064.

Who is the listed applicant for nView s1 with nav option?

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

What is the FDA product code for nView s1 with nav option?

The FDA product code for nView s1 with nav option is OWB.

Other records listing Nview Medical 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 optionK190064nView system 1

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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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