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FDA 510(k)

SimplECG

K-Number: K161431 · 2016-11-30

ApplicantNanowear, Inc.
Decision Date2016-11-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SimplECG is the device name listed in this FDA 510(k) record. The listed applicant is Nanowear, Inc.. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K161431. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SimplECG?

SimplECG is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Nanowear, Inc.. The 510(k) number is K161431.

When did SimplECG receive FDA 510(k) clearance?

SimplECG received FDA 510(k) clearance on 2016-11-30, under 510(k) number K161431.

Who is the listed applicant for SimplECG?

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

What is the FDA product code for SimplECG?

The FDA product code for SimplECG is DXH. This falls under the Hematology category.

Other records listing Nanowear, 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.

K232053SimpleSense-BP, SimpleSense-BP Software ApplicationK212160SimpleSENSE PlatformK201669SimpleSENSE

Related Devices (Code: DXH)

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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