FDA 510(k)

EOCENE SYSTEM

K-Number: K090712 · 2009-10-02

Decision Date2009-10-02

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EOCENE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Infopia Co, Ltd.. It received FDA 510(k) clearance on 2009-10-02 under 510(k) number K090712. 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 EOCENE SYSTEM?

EOCENE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-02. The listed applicant is Infopia Co, Ltd.. The 510(k) number is K090712.

When did EOCENE SYSTEM receive FDA 510(k) clearance?

EOCENE SYSTEM received FDA 510(k) clearance on 2009-10-02, under 510(k) number K090712.

Who is the listed applicant for EOCENE SYSTEM?

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

What is the FDA product code for EOCENE SYSTEM?

The FDA product code for EOCENE SYSTEM is NBW. This falls under the OB/GYN category.

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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.