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FDA 510(k)

MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT

K-Number: K974581 · 1998-10-28

Decision Date1998-10-28
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT 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 1998-10-28 under 510(k) number K974581. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT?

MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT is a medical device that received FDA 510(k) clearance on 1998-10-28. The listed applicant is Invivo Research, Inc.. The 510(k) number is K974581.

When did MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT receive FDA 510(k) clearance?

MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT received FDA 510(k) clearance on 1998-10-28, under 510(k) number K974581.

Who is the listed applicant for MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT?

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 MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT?

The FDA product code for MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT is DRT.

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.

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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Related Devices (Code: DRT)

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.

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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