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FDA 510(k)

OMEGA 5000

K-Number: K833978 · 1984-03-09

ApplicantInvivo Research Labs, Inc.
Decision Date1984-03-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMEGA 5000 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 1984-03-09 under 510(k) number K833978. 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 5000?

OMEGA 5000 is a medical device that received FDA 510(k) clearance on 1984-03-09. The listed applicant is Invivo Research Labs, Inc.. The 510(k) number is K833978.

When did OMEGA 5000 receive FDA 510(k) clearance?

OMEGA 5000 received FDA 510(k) clearance on 1984-03-09, under 510(k) number K833978.

Who is the listed applicant for OMEGA 5000?

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 OMEGA 5000?

The FDA product code for OMEGA 5000 is DXN.

Related Clinical Trials

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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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 4500K864889OMNI-TRAKK810838NEONATAL BLOOD PRESSURE CUFFK800066NIASTAT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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