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FDA 510(k)

MODEL 6000 TWO PARAMETER BEDSIDE MONITOR

K-Number: K091787 · 2009-10-09

ApplicantIvy Biomedical Systems, Inc.
Decision Date2009-10-09
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 6000 TWO PARAMETER BEDSIDE MONITOR 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 2009-10-09 under 510(k) number K091787. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 6000 TWO PARAMETER BEDSIDE MONITOR?

MODEL 6000 TWO PARAMETER BEDSIDE MONITOR is a medical device that received FDA 510(k) clearance on 2009-10-09. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K091787.

When did MODEL 6000 TWO PARAMETER BEDSIDE MONITOR receive FDA 510(k) clearance?

MODEL 6000 TWO PARAMETER BEDSIDE MONITOR received FDA 510(k) clearance on 2009-10-09, under 510(k) number K091787.

Who is the listed applicant for MODEL 6000 TWO PARAMETER BEDSIDE MONITOR?

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 MODEL 6000 TWO PARAMETER BEDSIDE MONITOR?

The FDA product code for MODEL 6000 TWO PARAMETER BEDSIDE MONITOR is DQA.

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Related Devices (Code: DQA)

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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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