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FDA 510(k)

STAT-SHELL DISPOSABLE SPO2 SENSOR

K-Number: K992092 · 1999-12-22

ApplicantEpic Medical Equipment Services, Inc.
Decision Date1999-12-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STAT-SHELL DISPOSABLE SPO2 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 1999-12-22 under 510(k) number K992092. 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 SPO2 SENSOR?

STAT-SHELL DISPOSABLE SPO2 SENSOR is a medical device that received FDA 510(k) clearance on 1999-12-22. The listed applicant is Epic Medical Equipment Services, Inc.. The 510(k) number is K992092.

When did STAT-SHELL DISPOSABLE SPO2 SENSOR receive FDA 510(k) clearance?

STAT-SHELL DISPOSABLE SPO2 SENSOR received FDA 510(k) clearance on 1999-12-22, under 510(k) number K992092.

Who is the listed applicant for STAT-SHELL DISPOSABLE SPO2 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 SPO2 SENSOR?

The FDA product code for STAT-SHELL DISPOSABLE SPO2 SENSOR is DQA.

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Other records listing Epic Medical Equipment Services, 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.

K012333FLEXI-SITE SP02 EAR SENSORK002848SPO2 WRAP SENSORK010718FLEXI-SITE SP02 EAR SENSORK002223EPIC SPO2 FINGER SENSOR, MODEL E412-20K000831STAT-SHELL DISPOSABLE SP02 SENSORK992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

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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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