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FDA 510(k)

FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS

K-Number: K041522 · 2004-09-14

ApplicantElekon Industries U.S.A., Inc.
Decision Date2004-09-14
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS 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 2004-09-14 under 510(k) number K041522. 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 FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS?

FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS is a medical device that received FDA 510(k) clearance on 2004-09-14. The listed applicant is Elekon Industries U.S.A., Inc.. The 510(k) number is K041522.

When did FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS receive FDA 510(k) clearance?

FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS received FDA 510(k) clearance on 2004-09-14, under 510(k) number K041522.

Who is the listed applicant for FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS?

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 DISPOSABLE ADHESIVE SPO2 SENSORS?

The FDA product code for FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS is DQA.

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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 SENSORSK042675FLEXI-STAT SP02 EAR SENSORK042704REUSABLE FINGER CLIP 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: 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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