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FDA 510(k)

SWEETSPOT DIABETES DATA MANAGEMENT SERVICE

K-Number: K111509 · 2011-11-09

ApplicantSweetspot Diabetes Care, Inc.
Decision Date2011-11-09
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SWEETSPOT DIABETES DATA MANAGEMENT SERVICE is the device name listed in this FDA 510(k) record. The listed applicant is Sweetspot Diabetes Care, Inc.. It received FDA 510(k) clearance on 2011-11-09 under 510(k) number K111509. 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 SWEETSPOT DIABETES DATA MANAGEMENT SERVICE?

SWEETSPOT DIABETES DATA MANAGEMENT SERVICE is a medical device that received FDA 510(k) clearance on 2011-11-09. The listed applicant is Sweetspot Diabetes Care, Inc.. The 510(k) number is K111509.

When did SWEETSPOT DIABETES DATA MANAGEMENT SERVICE receive FDA 510(k) clearance?

SWEETSPOT DIABETES DATA MANAGEMENT SERVICE received FDA 510(k) clearance on 2011-11-09, under 510(k) number K111509.

Who is the listed applicant for SWEETSPOT DIABETES DATA MANAGEMENT SERVICE?

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

What is the FDA product code for SWEETSPOT DIABETES DATA MANAGEMENT SERVICE?

The FDA product code for SWEETSPOT DIABETES DATA MANAGEMENT SERVICE is NBW. This falls under the OB/GYN category.

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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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