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FDA 510(k)

WiCap

K-Number: K160582 · 2016-09-02

ApplicantAthena Gtx
Decision Date2016-09-02
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WiCap is the device name listed in this FDA 510(k) record. The listed applicant is Athena Gtx. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K160582. 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 WiCap?

WiCap is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Athena Gtx. The 510(k) number is K160582.

When did WiCap receive FDA 510(k) clearance?

WiCap received FDA 510(k) clearance on 2016-09-02, under 510(k) number K160582.

Who is the listed applicant for WiCap?

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

What is the FDA product code for WiCap?

The FDA product code for WiCap is DQA.

Other records listing Athena Gtx 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.

K233354WVSM Pro (Series) (500-0030-XX)K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapK173203Athena GTX Device Management Suite (ADMS) SoftwareK153459TACVAC

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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