Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CardioBand ECG Event Recorder

K-Number: K181998 · 2018-11-15

ApplicantSamsung Strategy and Innovation Center (Ssic)
Decision Date2018-11-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioBand ECG Event Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Strategy and Innovation Center (Ssic). It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K181998. 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 CardioBand ECG Event Recorder?

CardioBand ECG Event Recorder is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Samsung Strategy and Innovation Center (Ssic). The 510(k) number is K181998.

When did CardioBand ECG Event Recorder receive FDA 510(k) clearance?

CardioBand ECG Event Recorder received FDA 510(k) clearance on 2018-11-15, under 510(k) number K181998.

Who is the listed applicant for CardioBand ECG Event Recorder?

The FDA 510(k) record lists Samsung Strategy and Innovation Center (Ssic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioBand ECG Event Recorder?

The FDA product code for CardioBand ECG Event Recorder 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.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

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.

↑