FDA 510(k)

THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)

K-Number: K061328 · 2006-06-13

Decision Date2006-06-13

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is E-San Limited. It received FDA 510(k) clearance on 2006-06-13 under 510(k) number K061328. 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 THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)?

THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) is a medical device that received FDA 510(k) clearance on 2006-06-13. The listed applicant is E-San Limited. The 510(k) number is K061328.

When did THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) receive FDA 510(k) clearance?

THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) received FDA 510(k) clearance on 2006-06-13, under 510(k) number K061328.

Who is the listed applicant for THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)?

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

What is the FDA product code for THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM)?

The FDA product code for THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) is NBW. This falls under the OB/GYN category.

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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.