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FDA 510(k)

SENSORMEDICS OXYSHUTTLE(TM)

K-Number: K862617 · 1986-09-26

ApplicantSensor Medics Corp.
Decision Date1986-09-26
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSORMEDICS OXYSHUTTLE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Sensor Medics Corp.. It received FDA 510(k) clearance on 1986-09-26 under 510(k) number K862617. 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 SENSORMEDICS OXYSHUTTLE(TM)?

SENSORMEDICS OXYSHUTTLE(TM) is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is Sensor Medics Corp.. The 510(k) number is K862617.

When did SENSORMEDICS OXYSHUTTLE(TM) receive FDA 510(k) clearance?

SENSORMEDICS OXYSHUTTLE(TM) received FDA 510(k) clearance on 1986-09-26, under 510(k) number K862617.

Who is the listed applicant for SENSORMEDICS OXYSHUTTLE(TM)?

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

What is the FDA product code for SENSORMEDICS OXYSHUTTLE(TM)?

The FDA product code for SENSORMEDICS OXYSHUTTLE(TM) is DQA.

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Other records listing Sensor Medics Corp. 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.

K032516HIOX80 AEROSOL ADAPTERK031745INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTIONK031883LYRA NASAL MASKK030943MODIFICATION TO HIOXK022192PEGASUS NASAL CPAP SYSTEMK020665HI-OX

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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.

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