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FDA 510(k)

MESI mTablet ECG Diagnostic System, MESI mTablet ECG

K-Number: K223670 · 2023-07-28

ApplicantMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
Decision Date2023-07-28
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MESI mTablet ECG Diagnostic System, MESI mTablet ECG is the device name listed in this FDA 510(k) record. The listed applicant is Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K223670. 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 MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

MESI mTablet ECG Diagnostic System, MESI mTablet ECG is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. The 510(k) number is K223670.

When did MESI mTablet ECG Diagnostic System, MESI mTablet ECG receive FDA 510(k) clearance?

MESI mTablet ECG Diagnostic System, MESI mTablet ECG received FDA 510(k) clearance on 2023-07-28, under 510(k) number K223670.

Who is the listed applicant for MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

The FDA 510(k) record lists Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

The FDA product code for MESI mTablet ECG Diagnostic System, MESI mTablet ECG is DPS.

Other records listing Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. 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.

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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.

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