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FDA 510(k)

502 OXYGEN SATURATION MONITOR

K-Number: K864613 · 1987-03-04

ApplicantCriticare Systems, Inc.
Decision Date1987-03-04
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

502 OXYGEN SATURATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Criticare Systems, Inc.. It received FDA 510(k) clearance on 1987-03-04 under 510(k) number K864613. 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 502 OXYGEN SATURATION MONITOR?

502 OXYGEN SATURATION MONITOR is a medical device that received FDA 510(k) clearance on 1987-03-04. The listed applicant is Criticare Systems, Inc.. The 510(k) number is K864613.

When did 502 OXYGEN SATURATION MONITOR receive FDA 510(k) clearance?

502 OXYGEN SATURATION MONITOR received FDA 510(k) clearance on 1987-03-04, under 510(k) number K864613.

Who is the listed applicant for 502 OXYGEN SATURATION MONITOR?

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

What is the FDA product code for 502 OXYGEN SATURATION MONITOR?

The FDA product code for 502 OXYGEN SATURATION MONITOR is DQA.

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Other records listing Criticare Systems, Inc. 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.

K101602VITAL SIGNS MONITORK091050506CN PATIENT MONITORK0425698600 VITAL SIGNS MONITORK030613VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100K022435507EL VITAL SIGNS MONITORK0120598100/8500 VITAL SIGNS MONITOR

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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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