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FDA 510(k)

PULSE-OX

K-Number: K863857 · 1987-10-07

ApplicantLife Design Systems, Inc.
Decision Date1987-10-07
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE-OX is the device name listed in this FDA 510(k) record. The listed applicant is Life Design Systems, Inc.. It received FDA 510(k) clearance on 1987-10-07 under 510(k) number K863857. 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 PULSE-OX?

PULSE-OX is a medical device that received FDA 510(k) clearance on 1987-10-07. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K863857.

When did PULSE-OX receive FDA 510(k) clearance?

PULSE-OX received FDA 510(k) clearance on 1987-10-07, under 510(k) number K863857.

Who is the listed applicant for PULSE-OX?

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

What is the FDA product code for PULSE-OX?

The FDA product code for PULSE-OX is DQA.

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Other records listing Life Design Systems, Inc. as applicant

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K913714MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM)K885313HUMIDI-FLEX TMK893030CHILD SIZE - FILTER FLEX (TM)K892862FLEX-CUP PERCUSSORK892221PULMONARY RESUSCITATOR, MODIFICATIONK890011OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING

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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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