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FDA 510(k)

WALDO PATIENT MONITOR

K-Number: K110334 · 2011-04-12

ApplicantWaldo Health
Decision Date2011-04-12
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WALDO PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Waldo Health. It received FDA 510(k) clearance on 2011-04-12 under 510(k) number K110334. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WALDO PATIENT MONITOR?

WALDO PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2011-04-12. The listed applicant is Waldo Health. The 510(k) number is K110334.

When did WALDO PATIENT MONITOR receive FDA 510(k) clearance?

WALDO PATIENT MONITOR received FDA 510(k) clearance on 2011-04-12, under 510(k) number K110334.

Who is the listed applicant for WALDO PATIENT MONITOR?

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

What is the FDA product code for WALDO PATIENT MONITOR?

The FDA product code for WALDO PATIENT MONITOR is DRG.

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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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