FDA 510(k)

AGAMATRIX HEALTH MANAGER

K-Number: K132821 · 2013-11-20

Decision Date2013-11-20

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AGAMATRIX HEALTH MANAGER is the device name listed in this FDA 510(k) record. The listed applicant is Agamatrix, Inc.. It received FDA 510(k) clearance on 2013-11-20 under 510(k) number K132821. 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 AGAMATRIX HEALTH MANAGER?

AGAMATRIX HEALTH MANAGER is a medical device that received FDA 510(k) clearance on 2013-11-20. The listed applicant is Agamatrix, Inc.. The 510(k) number is K132821.

When did AGAMATRIX HEALTH MANAGER receive FDA 510(k) clearance?

AGAMATRIX HEALTH MANAGER received FDA 510(k) clearance on 2013-11-20, under 510(k) number K132821.

Who is the listed applicant for AGAMATRIX HEALTH MANAGER?

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

What is the FDA product code for AGAMATRIX HEALTH MANAGER?

The FDA product code for AGAMATRIX HEALTH MANAGER 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.