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FDA 510(k)

MODIFICATION TO NICO WITH MARS, MODEL 7300

K-Number: K041450 · 2004-06-18

ApplicantRespironics Novametrix, Inc.
Decision Date2004-06-18
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO NICO WITH MARS, MODEL 7300 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 2004-06-18 under 510(k) number K041450. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO NICO WITH MARS, MODEL 7300?

MODIFICATION TO NICO WITH MARS, MODEL 7300 is a medical device that received FDA 510(k) clearance on 2004-06-18. The listed applicant is Respironics Novametrix, Inc.. The 510(k) number is K041450.

When did MODIFICATION TO NICO WITH MARS, MODEL 7300 receive FDA 510(k) clearance?

MODIFICATION TO NICO WITH MARS, MODEL 7300 received FDA 510(k) clearance on 2004-06-18, under 510(k) number K041450.

Who is the listed applicant for MODIFICATION TO NICO WITH MARS, MODEL 7300?

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 MODIFICATION TO NICO WITH MARS, MODEL 7300?

The FDA product code for MODIFICATION TO NICO WITH MARS, MODEL 7300 is CCK.

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Other records listing Respironics Novametrix, 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.

K092217MERCURY VCO2K042601CAPNOSTAT 5K032971TIDAL WAVE SP MODEL 710/715 AND 715K032949SPOT CHECK PULSE OXIMETER,512/513K032755MODEL 509M PULSE OXIMETER, MODEL 509MK030886NICO WITH MARS, MODEL 7300

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Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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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