Hero

FDA 510(k) K111601 · Medical Predictive Science Corp.

Substantially Equivalent

510(k) numberK111601

Submission

Device name
Hero
Applicant
Medical Predictive Science Corp.
Charlottesville, VA, US
Received
June 8, 2011
Decision date
July 8, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPS – Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2340
Specialty
Cardiovascular

Other 510(k)s with product code DPS

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K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional Edan Instruments, Inc.07/02/2026SE
K251670MAC 7 Resting ECG Analysis SystemDPS · Traditional Ge Medical Systems Information Technologies, Inc.01/26/2026SE
K252361AccurECG Analysis System (v2.0)DPS · Traditional Accurkardia, Inc.12/22/2025SE
K252474Withings BeamO (SCT02)DPS · Traditional Withings11/10/2025SE
K250569Cardiologs Holter PlatformDPS · Traditional Philips France Commercial08/06/2025SE
K243252ZBPro DiagnosticDPS · Traditional Zbeats, Inc.07/10/2025SE
K243305Masimo W1DPS · Traditional Masimo Corporation04/03/2025SE
K241217CloudHRV™ System (100-01-001)DPS · Traditional Inmedix, Inc.01/16/2025SE
K241556Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional Philips Medizin Systeme Böblingen GmbH12/17/2024SE
K240229Masimo W1DPS · Traditional Masimo Corporation08/08/2024SE

More from Masimo Corporation

510(k)DeviceDecision
K180242HeRO Symphony, HeRO ES, HeRO solo/duetDPS · Special 02/28/2018SE
K081473Hero, Version 2.0DPS · Special 06/27/2008SE

Questions and answers

When was Hero cleared by the FDA?

Hero (K111601) received a 510(k) decision of Substantially Equivalent on July 8, 2011, 30 days after the submission was received.

What is the product code of K111601?

The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.