Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EPIC SPO2 FINGER SENSOR, MODEL E412-20

K-Number: K002223 · 2000-08-22

ApplicantEpic Medical Equipment Services, Inc.
Decision Date2000-08-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPIC SPO2 FINGER SENSOR, MODEL E412-20 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 2000-08-22 under 510(k) number K002223. 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 E412-20?

EPIC SPO2 FINGER SENSOR, MODEL E412-20 is a medical device that received FDA 510(k) clearance on 2000-08-22. The listed applicant is Epic Medical Equipment Services, Inc.. The 510(k) number is K002223.

When did EPIC SPO2 FINGER SENSOR, MODEL E412-20 receive FDA 510(k) clearance?

EPIC SPO2 FINGER SENSOR, MODEL E412-20 received FDA 510(k) clearance on 2000-08-22, under 510(k) number K002223.

Who is the listed applicant for EPIC SPO2 FINGER SENSOR, MODEL E412-20?

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 E412-20?

The FDA product code for EPIC SPO2 FINGER SENSOR, MODEL E412-20 is DQA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SENSORK000831STAT-SHELL DISPOSABLE SP02 SENSORK992811TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGK992092STAT-SHELL DISPOSABLE SPO2 SENSOR

View all 13 devices →

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.

↑