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FDA 510(k)

DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE

K-Number: K864987 · 1987-03-03

ApplicantMedac, Inc.
Decision Date1987-03-03
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE is the device name listed in this FDA 510(k) record. The listed applicant is Medac, Inc.. It received FDA 510(k) clearance on 1987-03-03 under 510(k) number K864987. 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 DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE?

DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE is a medical device that received FDA 510(k) clearance on 1987-03-03. The listed applicant is Medac, Inc.. The 510(k) number is K864987.

When did DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE receive FDA 510(k) clearance?

DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE received FDA 510(k) clearance on 1987-03-03, under 510(k) number K864987.

Who is the listed applicant for DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE?

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

What is the FDA product code for DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE?

The FDA product code for DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE is DRO.

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Other records listing Medac, Inc. 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.

K874319MONITOR, ELECTROGRAPHICK874447DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELECK874090300M ECG MONITRO/TRANSCUTANEOUS PACEMAKERK874091360D DC DEFIBRILLATORK871176PACE 10 NON-INVASIVE EXTERNAL PACEMAKERK864985DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE

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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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