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FDA 510(k)

MOBCARDIO SYSTEM

K-Number: K113234 · 2011-11-17

ApplicantMobhealth Incorporation
Decision Date2011-11-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOBCARDIO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mobhealth Incorporation. It received FDA 510(k) clearance on 2011-11-17 under 510(k) number K113234. 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 MOBCARDIO SYSTEM?

MOBCARDIO SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-17. The listed applicant is Mobhealth Incorporation. The 510(k) number is K113234.

When did MOBCARDIO SYSTEM receive FDA 510(k) clearance?

MOBCARDIO SYSTEM received FDA 510(k) clearance on 2011-11-17, under 510(k) number K113234.

Who is the listed applicant for MOBCARDIO SYSTEM?

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

What is the FDA product code for MOBCARDIO SYSTEM?

The FDA product code for MOBCARDIO SYSTEM is DPS.

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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.

K254255S-Patch CardioAIWellysis Corp.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 Commercial

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.

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