FDA 510(k)

COPILOT HEALTH MANAGEMENT SYSTEM

K-Number: K062770 · 2006-12-14

Decision Date2006-12-14

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

COPILOT HEALTH MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2006-12-14 under 510(k) number K062770. 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 COPILOT HEALTH MANAGEMENT SYSTEM?

COPILOT HEALTH MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-14. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K062770.

When did COPILOT HEALTH MANAGEMENT SYSTEM receive FDA 510(k) clearance?

COPILOT HEALTH MANAGEMENT SYSTEM received FDA 510(k) clearance on 2006-12-14, under 510(k) number K062770.

Who is the listed applicant for COPILOT HEALTH MANAGEMENT SYSTEM?

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

What is the FDA product code for COPILOT HEALTH MANAGEMENT SYSTEM?

The FDA product code for COPILOT HEALTH MANAGEMENT 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.