FDA 510(k)

HERO

K-Number: K111601 · 2011-07-08

ApplicantMedical Predictive Science Corp.

Decision Date2011-07-08

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HERO 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 2011-07-08 under 510(k) number K111601. 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?

HERO is a medical device that received FDA 510(k) clearance on 2011-07-08. The listed applicant is Medical Predictive Science Corp.. The 510(k) number is K111601.

When did HERO receive FDA 510(k) clearance?

HERO received FDA 510(k) clearance on 2011-07-08, under 510(k) number K111601.

Who is the listed applicant for HERO?

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?

The FDA product code for HERO is DPS.

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.

K081473HERO, VERSION 2.0

Related Devices (Code: DPS)

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)Withings K250569Cardiologs Holter PlatformPhilips France Commercial

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.