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FDA 510(k)

ETP 180 CARDIAC PACEMAKER (EXTERNAL)

K-Number: K860551 · 1986-04-30

ApplicantBiotronics Corp.
Decision Date1986-04-30
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ETP 180 CARDIAC PACEMAKER (EXTERNAL) is the device name listed in this FDA 510(k) record. The listed applicant is Biotronics Corp.. It received FDA 510(k) clearance on 1986-04-30 under 510(k) number K860551. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETP 180 CARDIAC PACEMAKER (EXTERNAL)?

ETP 180 CARDIAC PACEMAKER (EXTERNAL) is a medical device that received FDA 510(k) clearance on 1986-04-30. The listed applicant is Biotronics Corp.. The 510(k) number is K860551.

When did ETP 180 CARDIAC PACEMAKER (EXTERNAL) receive FDA 510(k) clearance?

ETP 180 CARDIAC PACEMAKER (EXTERNAL) received FDA 510(k) clearance on 1986-04-30, under 510(k) number K860551.

Who is the listed applicant for ETP 180 CARDIAC PACEMAKER (EXTERNAL)?

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

What is the FDA product code for ETP 180 CARDIAC PACEMAKER (EXTERNAL)?

The FDA product code for ETP 180 CARDIAC PACEMAKER (EXTERNAL) is DRO.

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 Biotronics 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.

K771534BIOTRON 18

Related Devices (Code: DRO)

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.

K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data ElectronicsK983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, Inc.

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.

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