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FDA 510(k)

MODEL 509M PULSE OXIMETER, MODEL 509M

K-Number: K032755 · 2004-05-21

ApplicantRespironics Novametrix, Inc.
Decision Date2004-05-21
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 509M PULSE OXIMETER, MODEL 509M is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Novametrix, Inc.. It received FDA 510(k) clearance on 2004-05-21 under 510(k) number K032755. 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 MODEL 509M PULSE OXIMETER, MODEL 509M?

MODEL 509M PULSE OXIMETER, MODEL 509M is a medical device that received FDA 510(k) clearance on 2004-05-21. The listed applicant is Respironics Novametrix, Inc.. The 510(k) number is K032755.

When did MODEL 509M PULSE OXIMETER, MODEL 509M receive FDA 510(k) clearance?

MODEL 509M PULSE OXIMETER, MODEL 509M received FDA 510(k) clearance on 2004-05-21, under 510(k) number K032755.

Who is the listed applicant for MODEL 509M PULSE OXIMETER, MODEL 509M?

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

What is the FDA product code for MODEL 509M PULSE OXIMETER, MODEL 509M?

The FDA product code for MODEL 509M PULSE OXIMETER, MODEL 509M is DQA.

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Other records listing Respironics Novametrix, Inc. as applicant

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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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