FDA 510(k)

EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09

K-Number: K990082 · 1999-04-09

ApplicantEpic Medical Equipment Services, Inc.

Decision Date1999-04-09

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 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 1999-04-09 under 510(k) number K990082. 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 EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09?

EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 is a medical device that received FDA 510(k) clearance on 1999-04-09. The listed applicant is Epic Medical Equipment Services, Inc.. The 510(k) number is K990082.

When did EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 receive FDA 510(k) clearance?

EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 received FDA 510(k) clearance on 1999-04-09, under 510(k) number K990082.

Who is the listed applicant for EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09?

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 EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09?

The FDA product code for EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 is DQA.

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

K012333FLEXI-SITE SP02 EAR SENSOR K002848SPO2 WRAP SENSOR K010718FLEXI-SITE SP02 EAR SENSOR K002223EPIC SPO2 FINGER SENSOR, MODEL E412-20 K000831STAT-SHELL DISPOSABLE SP02 SENSOR K992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

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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.