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FDA 510(k)

STAT-SHELL DISPOSABLE SP02 SENSOR

K-Number: K000831 · 2000-06-05

ApplicantEpic Medical Equipment Services, Inc.
Decision Date2000-06-05
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STAT-SHELL DISPOSABLE SP02 SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Epic Medical Equipment Services, Inc.. It received FDA 510(k) clearance on 2000-06-05 under 510(k) number K000831. 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 STAT-SHELL DISPOSABLE SP02 SENSOR?

STAT-SHELL DISPOSABLE SP02 SENSOR is a medical device that received FDA 510(k) clearance on 2000-06-05. The listed applicant is Epic Medical Equipment Services, Inc.. The 510(k) number is K000831.

When did STAT-SHELL DISPOSABLE SP02 SENSOR receive FDA 510(k) clearance?

STAT-SHELL DISPOSABLE SP02 SENSOR received FDA 510(k) clearance on 2000-06-05, under 510(k) number K000831.

Who is the listed applicant for STAT-SHELL DISPOSABLE SP02 SENSOR?

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

What is the FDA product code for STAT-SHELL DISPOSABLE SP02 SENSOR?

The FDA product code for STAT-SHELL DISPOSABLE SP02 SENSOR is DQA.

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Other records listing Epic Medical Equipment Services, Inc. as applicant

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K012333FLEXI-SITE SP02 EAR SENSORK002848SPO2 WRAP SENSORK010718FLEXI-SITE SP02 EAR SENSORK002223EPIC SPO2 FINGER SENSOR, MODEL E412-20K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGK992211SPO2 WRAP SENSOR

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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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