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FDA 510(k)

OMNI-TRAK (PATIENT MONITOR)

K-Number: K890817 · 1989-08-10

ApplicantInvivo Research, Inc.
Decision Date1989-08-10
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OMNI-TRAK (PATIENT MONITOR) is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Research, Inc.. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K890817. 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 OMNI-TRAK (PATIENT MONITOR)?

OMNI-TRAK (PATIENT MONITOR) is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Invivo Research, Inc.. The 510(k) number is K890817.

When did OMNI-TRAK (PATIENT MONITOR) receive FDA 510(k) clearance?

OMNI-TRAK (PATIENT MONITOR) received FDA 510(k) clearance on 1989-08-10, under 510(k) number K890817.

Who is the listed applicant for OMNI-TRAK (PATIENT MONITOR)?

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

What is the FDA product code for OMNI-TRAK (PATIENT MONITOR)?

The FDA product code for OMNI-TRAK (PATIENT MONITOR) is CCK.

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Other records listing Invivo Research, 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.

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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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