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FDA 510(k)

ACG-8511 PORTABLE ECG MONITOR

K-Number: K110328 · 2011-07-15

ApplicantAndon Health Co, Ltd.
Decision Date2011-07-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACG-8511 PORTABLE ECG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2011-07-15 under 510(k) number K110328. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACG-8511 PORTABLE ECG MONITOR?

ACG-8511 PORTABLE ECG MONITOR is a medical device that received FDA 510(k) clearance on 2011-07-15. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K110328.

When did ACG-8511 PORTABLE ECG MONITOR receive FDA 510(k) clearance?

ACG-8511 PORTABLE ECG MONITOR received FDA 510(k) clearance on 2011-07-15, under 510(k) number K110328.

Who is the listed applicant for ACG-8511 PORTABLE ECG MONITOR?

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

What is the FDA product code for ACG-8511 PORTABLE ECG MONITOR?

The FDA product code for ACG-8511 PORTABLE ECG MONITOR is DPS.

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Related Devices (Code: DPS)

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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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