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FDA 510(k)

CheckMyHeart Plus

K-Number: K172778 · 2018-07-05

ApplicantDailycare Biomedical, Inc.
Decision Date2018-07-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CheckMyHeart Plus is the device name listed in this FDA 510(k) record. The listed applicant is Dailycare Biomedical, Inc.. It received FDA 510(k) clearance on 2018-07-05 under 510(k) number K172778. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CheckMyHeart Plus?

CheckMyHeart Plus is a medical device that received FDA 510(k) clearance on 2018-07-05. The listed applicant is Dailycare Biomedical, Inc.. The 510(k) number is K172778.

When did CheckMyHeart Plus receive FDA 510(k) clearance?

CheckMyHeart Plus received FDA 510(k) clearance on 2018-07-05, under 510(k) number K172778.

Who is the listed applicant for CheckMyHeart Plus?

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

What is the FDA product code for CheckMyHeart Plus?

The FDA product code for CheckMyHeart Plus is DPS.

Related Devices (Code: DPS)

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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