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FDA 510(k)

SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598

K-Number: K083395 · 2009-02-27

ApplicantAndon Health Co, Ltd.
Decision Date2009-02-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 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 2009-02-27 under 510(k) number K083395. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598?

SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K083395.

When did SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 receive FDA 510(k) clearance?

SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 received FDA 510(k) clearance on 2009-02-27, under 510(k) number K083395.

Who is the listed applicant for SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598?

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 SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598?

The FDA product code for SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 is DXN.

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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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