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FDA 510(k)

HOMMED SENTRY III PATIENT MONITOR SYSTEM

K-Number: K004044 · 2001-03-02

ApplicantHommed, LLC
Decision Date2001-03-02
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOMMED SENTRY III PATIENT MONITOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hommed, LLC. It received FDA 510(k) clearance on 2001-03-02 under 510(k) number K004044. 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 HOMMED SENTRY III PATIENT MONITOR SYSTEM?

HOMMED SENTRY III PATIENT MONITOR SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-02. The listed applicant is Hommed, LLC. The 510(k) number is K004044.

When did HOMMED SENTRY III PATIENT MONITOR SYSTEM receive FDA 510(k) clearance?

HOMMED SENTRY III PATIENT MONITOR SYSTEM received FDA 510(k) clearance on 2001-03-02, under 510(k) number K004044.

Who is the listed applicant for HOMMED SENTRY III PATIENT MONITOR SYSTEM?

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

What is the FDA product code for HOMMED SENTRY III PATIENT MONITOR SYSTEM?

The FDA product code for HOMMED SENTRY III PATIENT MONITOR SYSTEM is DQA.

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Other records listing Hommed, LLC 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.

K040799HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONSK040651HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEMK040032CENTRAL STATION, VERSION 3.3HK020184HOMMED CENTRAL STATIONK014025HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READERK003180HOMMED OBSERVER, MODEL I

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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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