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FDA 510(k)

MARSPO2, MODEL 2001

K-Number: K993979 · 2000-02-22

ApplicantNovametrix Medical Systems, Inc.
Decision Date2000-02-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MARSPO2, MODEL 2001 is the device name listed in this FDA 510(k) record. The listed applicant is Novametrix Medical Systems, Inc.. It received FDA 510(k) clearance on 2000-02-22 under 510(k) number K993979. 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 MARSPO2, MODEL 2001?

MARSPO2, MODEL 2001 is a medical device that received FDA 510(k) clearance on 2000-02-22. The listed applicant is Novametrix Medical Systems, Inc.. The 510(k) number is K993979.

When did MARSPO2, MODEL 2001 receive FDA 510(k) clearance?

MARSPO2, MODEL 2001 received FDA 510(k) clearance on 2000-02-22, under 510(k) number K993979.

Who is the listed applicant for MARSPO2, MODEL 2001?

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

What is the FDA product code for MARSPO2, MODEL 2001?

The FDA product code for MARSPO2, MODEL 2001 is DQA.

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Other records listing Novametrix Medical Systems, 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.

K010451NOVAMETRIX MARQUETTE COMPATIBLE SENSORSK000794MODIFICATION TO MARSPO2, MODEL 2001K982499COSMO PLUS WITH NICO, MODEL 8200K964360VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101K963380CO 2 SMO PLUSK963327TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610

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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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