FDA 510(k)

CARDIOSTRESS

K-Number: K820011 · 1982-01-22

ApplicantInstruments For Cardiac Research

Decision Date1982-01-22

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARDIOSTRESS is the device name listed in this FDA 510(k) record. The listed applicant is Instruments For Cardiac Research. It received FDA 510(k) clearance on 1982-01-22 under 510(k) number K820011. 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 CARDIOSTRESS?

CARDIOSTRESS is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Instruments For Cardiac Research. The 510(k) number is K820011.

When did CARDIOSTRESS receive FDA 510(k) clearance?

CARDIOSTRESS received FDA 510(k) clearance on 1982-01-22, under 510(k) number K820011.

Who is the listed applicant for CARDIOSTRESS?

The FDA 510(k) record lists Instruments For Cardiac Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOSTRESS?

The FDA product code for CARDIOSTRESS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Instruments For Cardiac Research as applicant

K834397HOLTER CARDIOGRAPHY SYS 6201 K821173EVENTMASTER 3 HOLTER EVENT SCANNER K820856EVENTMASTER 2 K812920EVENT MASTER K801903SERIES 4000 STRESS & EXERCISE SYSTEM K771374SCANNER TREND SYSTEM

View all 8 devices →

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.