Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CARDIO DATA PACERECORDER PR3

K-Number: K853262 · 1985-10-11

ApplicantCardio Data
Decision Date1985-10-11
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO DATA PACERECORDER PR3 is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Data. It received FDA 510(k) clearance on 1985-10-11 under 510(k) number K853262. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO DATA PACERECORDER PR3?

CARDIO DATA PACERECORDER PR3 is a medical device that received FDA 510(k) clearance on 1985-10-11. The listed applicant is Cardio Data. The 510(k) number is K853262.

When did CARDIO DATA PACERECORDER PR3 receive FDA 510(k) clearance?

CARDIO DATA PACERECORDER PR3 received FDA 510(k) clearance on 1985-10-11, under 510(k) number K853262.

Who is the listed applicant for CARDIO DATA PACERECORDER PR3?

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

What is the FDA product code for CARDIO DATA PACERECORDER PR3?

The FDA product code for CARDIO DATA PACERECORDER PR3 is DSH.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardio Data 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.

K850136CARDIO DATA MK4 HOLTER ANALYSIS SYSTEMK834257CARDIODATA PACE RECORDERK831184CARDIO DATA PACEMAKER RECORDERK812149CARDIO-DATA SYSTEM, #MARK IIIK770264PACEGUARD

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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.

↑