Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Wesper, Inc.. It received FDA 510(k) clearance on 2022-06-10 under 510(k) 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. The listed applicant is Wesper, Inc.. The 510(k) number is K213515.

When did WesperO2 receive FDA 510(k) clearance?

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

Who is the listed applicant for WesperO2?

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

What is the FDA product code for WesperO2?

The FDA product code for WesperO2 is DQA.

Other records listing Wesper, 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.

K252628CASSIEK221816Wesper LabK203343Wesper Lab

Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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.

↑