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FDA 510(k)

PROFOX SOFTWARE, MODEL 920M-41

K-Number: K001708 · 2001-03-01

ApplicantRespironics Georgia, Inc.
Decision Date2001-03-01
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROFOX SOFTWARE, MODEL 920M-41 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Georgia, Inc.. It received FDA 510(k) clearance on 2001-03-01 under 510(k) number K001708. 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 PROFOX SOFTWARE, MODEL 920M-41?

PROFOX SOFTWARE, MODEL 920M-41 is a medical device that received FDA 510(k) clearance on 2001-03-01. The listed applicant is Respironics Georgia, Inc.. The 510(k) number is K001708.

When did PROFOX SOFTWARE, MODEL 920M-41 receive FDA 510(k) clearance?

PROFOX SOFTWARE, MODEL 920M-41 received FDA 510(k) clearance on 2001-03-01, under 510(k) number K001708.

Who is the listed applicant for PROFOX SOFTWARE, MODEL 920M-41?

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

What is the FDA product code for PROFOX SOFTWARE, MODEL 920M-41?

The FDA product code for PROFOX SOFTWARE, MODEL 920M-41 is DQA.

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Other records listing Respironics Georgia, 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.

K011597SMARTMONITOR 2, MODEL 4000

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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