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FDA 510(k)

WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4

K-Number: K101597 · 2010-10-18

ApplicantAgamatrix
Decision Date2010-10-18
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 is the device name listed in this FDA 510(k) record. The listed applicant is Agamatrix. It received FDA 510(k) clearance on 2010-10-18 under 510(k) number K101597. 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 WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4?

WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 is a medical device that received FDA 510(k) clearance on 2010-10-18. The listed applicant is Agamatrix. The 510(k) number is K101597.

When did WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 receive FDA 510(k) clearance?

WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 received FDA 510(k) clearance on 2010-10-18, under 510(k) number K101597.

Who is the listed applicant for WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4?

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

What is the FDA product code for WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4?

The FDA product code for WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 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

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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