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FDA 510(k)

OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES

K-Number: K002030 · 2000-09-26

ApplicantInvivo Research, Inc.
Decision Date2000-09-26
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES 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 2000-09-26 under 510(k) number K002030. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES?

OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES is a medical device that received FDA 510(k) clearance on 2000-09-26. The listed applicant is Invivo Research, Inc.. The 510(k) number is K002030.

When did OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES receive FDA 510(k) clearance?

OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES received FDA 510(k) clearance on 2000-09-26, under 510(k) number K002030.

Who is the listed applicant for OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES?

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 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES?

The FDA product code for OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES is MWI.

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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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