Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMNI-TRAK

K-Number: K864889 · 1987-03-06

ApplicantInvivo Research Labs, Inc.
Decision Date1987-03-06
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNI-TRAK is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Research Labs, Inc.. It received FDA 510(k) clearance on 1987-03-06 under 510(k) number K864889. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-TRAK?

OMNI-TRAK is a medical device that received FDA 510(k) clearance on 1987-03-06. The listed applicant is Invivo Research Labs, Inc.. The 510(k) number is K864889.

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

OMNI-TRAK received FDA 510(k) clearance on 1987-03-06, under 510(k) number K864889.

Who is the listed applicant for OMNI-TRAK?

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

What is the FDA product code for OMNI-TRAK?

The FDA product code for OMNI-TRAK is DSB.

Other records listing Invivo Research Labs, 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.

K864730INVIVO PULSE OXIMETER, MODEL 4500K833978OMEGA 5000K810838NEONATAL BLOOD PRESSURE CUFFK800066NIASTAT

Related Devices (Code: DSB)

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.

K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed LimitedK250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLCK243727Re:BalansMode Sensors ASK250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical , Ltd.K232089SOZO ProImpediMed LimitedK223217Zynex Monitoring System, Model CM-1600Zynex Medical, 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.

↑