FDA 510(k)

MobileECG 2 BT

K-Number: K181658 · 2019-03-26

Decision Date2019-03-26

Product CodeDSI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MobileECG 2 BT is the device name listed in this FDA 510(k) record. The listed applicant is Memtec Corporation. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K181658. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MobileECG 2 BT?

MobileECG 2 BT is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Memtec Corporation. The 510(k) number is K181658.

When did MobileECG 2 BT receive FDA 510(k) clearance?

MobileECG 2 BT received FDA 510(k) clearance on 2019-03-26, under 510(k) number K181658.

Who is the listed applicant for MobileECG 2 BT?

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

What is the FDA product code for MobileECG 2 BT?

The FDA product code for MobileECG 2 BT is DSI.

Related Devices (Code: DSI)

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.