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FDA 510(k)

HERO, VERSION 2.0

K-Number: K081473 · 2008-06-27

ApplicantMedical Predictive Science Corp.
Decision Date2008-06-27
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HERO, VERSION 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Predictive Science Corp.. It received FDA 510(k) clearance on 2008-06-27 under 510(k) number K081473. 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 HERO, VERSION 2.0?

HERO, VERSION 2.0 is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is Medical Predictive Science Corp.. The 510(k) number is K081473.

When did HERO, VERSION 2.0 receive FDA 510(k) clearance?

HERO, VERSION 2.0 received FDA 510(k) clearance on 2008-06-27, under 510(k) number K081473.

Who is the listed applicant for HERO, VERSION 2.0?

The FDA 510(k) record lists Medical Predictive Science Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERO, VERSION 2.0?

The FDA product code for HERO, VERSION 2.0 is DPS.

Related Clinical Trials

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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Other records listing Medical Predictive Science Corp. 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.

K111601HERO

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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