FDA 510(k)

COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR

K-Number: K960251 · 1996-03-26

Decision Date1996-03-26

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Aristo Medical Products, Inc.. It received FDA 510(k) clearance on 1996-03-26 under 510(k) number K960251. 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 COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR?

COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR is a medical device that received FDA 510(k) clearance on 1996-03-26. The listed applicant is Aristo Medical Products, Inc.. The 510(k) number is K960251.

When did COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR receive FDA 510(k) clearance?

COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR received FDA 510(k) clearance on 1996-03-26, under 510(k) number K960251.

Who is the listed applicant for COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR?

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

What is the FDA product code for COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR?

The FDA product code for COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR is DQA.

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Other records listing Aristo Medical Products, Inc. as applicant

K961060ARISTO ESOPHAGEAL STETHOSCOPE K953817ARISTO MEDICAL MODEL 2101 PATIENT MONITOR K920966SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT)

Related Devices (Code: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse 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 Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita Corporation K252805YUWELL® 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.