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FDA 510(k)

WesperO2

K-Number: K213515 · 2022-06-10

ApplicantWesper, Inc.
Decision Date2022-06-10
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WesperO2 is a medical device manufactured by Wesper, Inc.. It received FDA 510(k) clearance on 2022-06-10 under approval number K213515. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WesperO2?

WesperO2 is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Wesper, Inc.. The 510(k) number is K213515.

When was WesperO2 approved by the FDA?

WesperO2 received FDA 510(k) clearance on 2022-06-10, under approval number K213515.

What company makes WesperO2?

WesperO2 is manufactured by Wesper, Inc..

What is the FDA product code for WesperO2?

The FDA product code for WesperO2 is DQA.

Other Devices by Wesper, Inc.

K203343Wesper Lab K221816Wesper Lab K252628CASSIE

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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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