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FDA 510(k)

FLEXI-STAT SP02 EAR SENSOR

K-Number: K042675 · 2004-12-06

ApplicantElekon Industries U.S.A., Inc.
Decision Date2004-12-06
Product CodeDPZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXI-STAT SP02 EAR SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Elekon Industries U.S.A., Inc.. It received FDA 510(k) clearance on 2004-12-06 under 510(k) number K042675. The device is classified under product code DPZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXI-STAT SP02 EAR SENSOR?

FLEXI-STAT SP02 EAR SENSOR is a medical device that received FDA 510(k) clearance on 2004-12-06. The listed applicant is Elekon Industries U.S.A., Inc.. The 510(k) number is K042675.

When did FLEXI-STAT SP02 EAR SENSOR receive FDA 510(k) clearance?

FLEXI-STAT SP02 EAR SENSOR received FDA 510(k) clearance on 2004-12-06, under 510(k) number K042675.

Who is the listed applicant for FLEXI-STAT SP02 EAR SENSOR?

The FDA 510(k) record lists Elekon Industries U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXI-STAT SP02 EAR SENSOR?

The FDA product code for FLEXI-STAT SP02 EAR SENSOR is DPZ.

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.

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Other records listing Elekon Industries U.S.A., 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.

K042705DISPOSABLE NON-ADHESIVE SPO2 SENSORSK042704REUSABLE FINGER CLIP SPO2 SENSORSK041522FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORSK041647FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)K041644FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

Related Devices (Code: DPZ)

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.

K040831DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.K012333FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.K010718FLEXI-SITE SP02 EAR SENSOREpic Medical Equipment Services, Inc.K944760DURA-Y OXYGEN TRANSDUCER, EAR CLIPNellcor, Inc.K942752MARQUETTE EAR PROBE SENSORMarquette Electronics, Inc.K914595PULSE RATE MONITORFitness Quest, Inc.

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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