FDA 510(k)

ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528

K-Number: K062434 · 2006-11-13

Decision Date2006-11-13

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 is the device name listed in this FDA 510(k) record. The listed applicant is Agamatrix. It received FDA 510(k) clearance on 2006-11-13 under 510(k) number K062434. 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 ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528?

ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 is a medical device that received FDA 510(k) clearance on 2006-11-13. The listed applicant is Agamatrix. The 510(k) number is K062434.

When did ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 receive FDA 510(k) clearance?

ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 received FDA 510(k) clearance on 2006-11-13, under 510(k) number K062434.

Who is the listed applicant for ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528?

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

What is the FDA product code for ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528?

The FDA product code for ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 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.