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FDA 510(k)

VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES

K-Number: K031740 · 2003-08-26

ApplicantWelch Allyn Protocol, Inc.
Decision Date2003-08-26
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn Protocol, Inc.. It received FDA 510(k) clearance on 2003-08-26 under 510(k) number K031740. 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 VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES?

VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES is a medical device that received FDA 510(k) clearance on 2003-08-26. The listed applicant is Welch Allyn Protocol, Inc.. The 510(k) number is K031740.

When did VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES receive FDA 510(k) clearance?

VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES received FDA 510(k) clearance on 2003-08-26, under 510(k) number K031740.

Who is the listed applicant for VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES?

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

What is the FDA product code for VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES?

The FDA product code for VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES is DQA.

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Other records listing Welch Allyn Protocol, 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.

K070204LINK TO ACUITY CLINICIAN NOTIFIERK063419MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )K033378VITAL SIGNS MONITOR, PROPAQ LTK022453MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEMK021681MICROPAQ, MODELS 402, 404K012451PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246

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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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