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FDA 510(k)

OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS

K-Number: K945138 · 1995-11-20

ApplicantInvivo Research, Inc.
Decision Date1995-11-20
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS 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 1995-11-20 under 510(k) number K945138. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS?

OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Invivo Research, Inc.. The 510(k) number is K945138.

When did OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS receive FDA 510(k) clearance?

OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS received FDA 510(k) clearance on 1995-11-20, under 510(k) number K945138.

Who is the listed applicant for OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS?

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 OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS?

The FDA product code for OMEGA 5600 SERIES NON-INVASIVE BLOOD PRESSURE MONITORS is DXN.

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Related Devices (Code: DXN)

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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