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FDA 510(k)

Health-e-Connect System with IDA

K-Number: K163664 · 2017-09-18

ApplicantAlr Technologies
Decision Date2017-09-18
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Health-e-Connect System with IDA is the device name listed in this FDA 510(k) record. The listed applicant is Alr Technologies. It received FDA 510(k) clearance on 2017-09-18 under 510(k) number K163664. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Health-e-Connect System with IDA?

Health-e-Connect System with IDA is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Alr Technologies. The 510(k) number is K163664.

When did Health-e-Connect System with IDA receive FDA 510(k) clearance?

Health-e-Connect System with IDA received FDA 510(k) clearance on 2017-09-18, under 510(k) number K163664.

Who is the listed applicant for Health-e-Connect System with IDA?

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

What is the FDA product code for Health-e-Connect System with IDA?

The FDA product code for Health-e-Connect System with IDA is NDC.

Related Devices (Code: NDC)

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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