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FDA 510(k)

ANDROFLOW - RESPIRATORY RATE MONITOR

K-Number: K051779 · 2005-09-30

ApplicantAndromed, Inc.
Decision Date2005-09-30
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANDROFLOW - RESPIRATORY RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Andromed, Inc.. It received FDA 510(k) clearance on 2005-09-30 under 510(k) number K051779. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANDROFLOW - RESPIRATORY RATE MONITOR?

ANDROFLOW - RESPIRATORY RATE MONITOR is a medical device that received FDA 510(k) clearance on 2005-09-30. The listed applicant is Andromed, Inc.. The 510(k) number is K051779.

When did ANDROFLOW - RESPIRATORY RATE MONITOR receive FDA 510(k) clearance?

ANDROFLOW - RESPIRATORY RATE MONITOR received FDA 510(k) clearance on 2005-09-30, under 510(k) number K051779.

Who is the listed applicant for ANDROFLOW - RESPIRATORY RATE MONITOR?

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

What is the FDA product code for ANDROFLOW - RESPIRATORY RATE MONITOR?

The FDA product code for ANDROFLOW - RESPIRATORY RATE MONITOR is BZQ.

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Official Source

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