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FDA 510(k)

OXYTRAK(TM) PULSE OXIMETER

K-Number: K894100 · 1990-05-09

ApplicantCritikon Company, LLC
Decision Date1990-05-09
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OXYTRAK(TM) PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1990-05-09 under 510(k) number K894100. 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 OXYTRAK(TM) PULSE OXIMETER?

OXYTRAK(TM) PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 1990-05-09. The listed applicant is Critikon Company, LLC. The 510(k) number is K894100.

When did OXYTRAK(TM) PULSE OXIMETER receive FDA 510(k) clearance?

OXYTRAK(TM) PULSE OXIMETER received FDA 510(k) clearance on 1990-05-09, under 510(k) number K894100.

Who is the listed applicant for OXYTRAK(TM) PULSE OXIMETER?

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

What is the FDA product code for OXYTRAK(TM) PULSE OXIMETER?

The FDA product code for OXYTRAK(TM) PULSE OXIMETER is DQA.

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Other records listing Critikon Company, LLC 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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400K982342DINAMAP MPS SELECT PORTABLE MONITORK943709DINAMAP PLUS VITAL SIGNS MONOITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

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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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