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FDA 510(k)

PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)

K-Number: K023616 · 2002-11-04

ApplicantIvy Biomedical Systems, Inc.
Decision Date2002-11-04
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2002-11-04 under 510(k) number K023616. 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 PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)?

PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) is a medical device that received FDA 510(k) clearance on 2002-11-04. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K023616.

When did PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) receive FDA 510(k) clearance?

PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) received FDA 510(k) clearance on 2002-11-04, under 510(k) number K023616.

Who is the listed applicant for PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)?

The FDA 510(k) record lists Ivy Biomedical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)?

The FDA product code for PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) is DRT.

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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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