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FDA 510(k)

CIV-OB (PLUS)

K-Number: K103172 · 2011-03-11

ApplicantCivnet Communication, Ltd.
Decision Date2011-03-11
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CIV-OB (PLUS) is the device name listed in this FDA 510(k) record. The listed applicant is Civnet Communication, Ltd.. It received FDA 510(k) clearance on 2011-03-11 under 510(k) number K103172. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIV-OB (PLUS)?

CIV-OB (PLUS) is a medical device that received FDA 510(k) clearance on 2011-03-11. The listed applicant is Civnet Communication, Ltd.. The 510(k) number is K103172.

When did CIV-OB (PLUS) receive FDA 510(k) clearance?

CIV-OB (PLUS) received FDA 510(k) clearance on 2011-03-11, under 510(k) number K103172.

Who is the listed applicant for CIV-OB (PLUS)?

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

What is the FDA product code for CIV-OB (PLUS)?

The FDA product code for CIV-OB (PLUS) is HGM.

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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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