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FDA 510(k)

CADWELL EASYNET OXIMETER MODULE

K-Number: K061706 · 2007-03-05

ApplicantCadwell Laboratories, Inc.
Decision Date2007-03-05
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CADWELL EASYNET OXIMETER MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 2007-03-05 under 510(k) number K061706. 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 CADWELL EASYNET OXIMETER MODULE?

CADWELL EASYNET OXIMETER MODULE is a medical device that received FDA 510(k) clearance on 2007-03-05. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K061706.

When did CADWELL EASYNET OXIMETER MODULE receive FDA 510(k) clearance?

CADWELL EASYNET OXIMETER MODULE received FDA 510(k) clearance on 2007-03-05, under 510(k) number K061706.

Who is the listed applicant for CADWELL EASYNET OXIMETER MODULE?

The FDA 510(k) record lists Cadwell Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CADWELL EASYNET OXIMETER MODULE?

The FDA product code for CADWELL EASYNET OXIMETER MODULE is DQA.

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Other records listing Cadwell Laboratories, 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.

K061705CADWELL EASYNET NASAL PRESSURE MODULEK042350TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATORK040932EASYNET BODY POSITION MODULEK040986CADWELL LIMB MOVEMENT MODULEK971214KILOWINK962455FOUR-CHANNEL PREAMPLIFIER

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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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