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FDA 510(k)

GLOOKO LOGBOOK CHARTS

K-Number: K122142 · 2012-12-21

ApplicantGlooko, Inc.
Decision Date2012-12-21
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLOOKO LOGBOOK CHARTS is the device name listed in this FDA 510(k) record. The listed applicant is Glooko, Inc.. It received FDA 510(k) clearance on 2012-12-21 under 510(k) number K122142. 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 GLOOKO LOGBOOK CHARTS?

GLOOKO LOGBOOK CHARTS is a medical device that received FDA 510(k) clearance on 2012-12-21. The listed applicant is Glooko, Inc.. The 510(k) number is K122142.

When did GLOOKO LOGBOOK CHARTS receive FDA 510(k) clearance?

GLOOKO LOGBOOK CHARTS received FDA 510(k) clearance on 2012-12-21, under 510(k) number K122142.

Who is the listed applicant for GLOOKO LOGBOOK CHARTS?

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

What is the FDA product code for GLOOKO LOGBOOK CHARTS?

The FDA product code for GLOOKO LOGBOOK CHARTS is NBW. This falls under the OB/GYN category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Glooko, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260910EndoTool IV Cloud 1.0K171450Glooko Mobile Insulin Dosing SystemK132272GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATIONK130886GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION

Related Devices (Code: NBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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