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FDA 510(k)

INTOUCH DIABETES

K-Number: K093789 · 2010-02-19

ApplicantSymcare Personalized Health Solutions, Inc.
Decision Date2010-02-19
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INTOUCH DIABETES is the device name listed in this FDA 510(k) record. The listed applicant is Symcare Personalized Health Solutions, Inc.. It received FDA 510(k) clearance on 2010-02-19 under 510(k) number K093789. 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 INTOUCH DIABETES?

INTOUCH DIABETES is a medical device that received FDA 510(k) clearance on 2010-02-19. The listed applicant is Symcare Personalized Health Solutions, Inc.. The 510(k) number is K093789.

When did INTOUCH DIABETES receive FDA 510(k) clearance?

INTOUCH DIABETES received FDA 510(k) clearance on 2010-02-19, under 510(k) number K093789.

Who is the listed applicant for INTOUCH DIABETES?

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

What is the FDA product code for INTOUCH DIABETES?

The FDA product code for INTOUCH DIABETES 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 Symcare Personalized Health Solutions, 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.

K083263SYMCARE DIABETES MANAGEMENT PROGRAM

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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