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FDA 510(k)

BIONIME DIABETES MANAGEMENT SYSTEM VI.0

K-Number: K113007 · 2012-02-27

ApplicantBionime Corporation
Decision Date2012-02-27
Product CodeJQP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIONIME DIABETES MANAGEMENT SYSTEM VI.0 is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2012-02-27 under 510(k) number K113007. The device is classified under product code JQP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIONIME DIABETES MANAGEMENT SYSTEM VI.0?

BIONIME DIABETES MANAGEMENT SYSTEM VI.0 is a medical device that received FDA 510(k) clearance on 2012-02-27. The listed applicant is Bionime Corporation. The 510(k) number is K113007.

When did BIONIME DIABETES MANAGEMENT SYSTEM VI.0 receive FDA 510(k) clearance?

BIONIME DIABETES MANAGEMENT SYSTEM VI.0 received FDA 510(k) clearance on 2012-02-27, under 510(k) number K113007.

Who is the listed applicant for BIONIME DIABETES MANAGEMENT SYSTEM VI.0?

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

What is the FDA product code for BIONIME DIABETES MANAGEMENT SYSTEM VI.0?

The FDA product code for BIONIME DIABETES MANAGEMENT SYSTEM VI.0 is JQP.

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Related Devices (Code: JQP)

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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.

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