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FDA 510(k)

OMNI-TRAK PATIENT MONITORING SYSTEM

K-Number: K955045 · 1996-07-11

ApplicantInvivo Research, Inc.
Decision Date1996-07-11
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNI-TRAK PATIENT MONITORING SYSTEM 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 1996-07-11 under 510(k) number K955045. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-TRAK PATIENT MONITORING SYSTEM?

OMNI-TRAK PATIENT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-07-11. The listed applicant is Invivo Research, Inc.. The 510(k) number is K955045.

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

OMNI-TRAK PATIENT MONITORING SYSTEM received FDA 510(k) clearance on 1996-07-11, under 510(k) number K955045.

Who is the listed applicant for OMNI-TRAK PATIENT MONITORING SYSTEM?

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 MONITORING SYSTEM?

The FDA product code for OMNI-TRAK PATIENT MONITORING SYSTEM is DPS.

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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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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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