FDA 510(k)

ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE

K-Number: K112738 · 2011-09-30

Decision Date2011-09-30

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Andon Medical Co., Ltd.. It received FDA 510(k) clearance on 2011-09-30 under 510(k) number K112738. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE?

ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE is a medical device that received FDA 510(k) clearance on 2011-09-30. The listed applicant is Andon Medical Co., Ltd.. The 510(k) number is K112738.

When did ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE receive FDA 510(k) clearance?

ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE received FDA 510(k) clearance on 2011-09-30, under 510(k) number K112738.

Who is the listed applicant for ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE?

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

What is the FDA product code for ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE?

The FDA product code for ANDON HEALTH CARE MANAGEMENT SYSTEM SOFTWARE is NBW. This falls under the OB/GYN category.

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Other records listing Andon Medical Co., Ltd. as applicant

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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.