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FDA 510(k)

LECTEC NON-INVASIVE PACING ELECTRODE

K-Number: K872012 · 1987-06-29

ApplicantLectec Corp.
Decision Date1987-06-29
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LECTEC NON-INVASIVE PACING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Lectec Corp.. It received FDA 510(k) clearance on 1987-06-29 under 510(k) number K872012. 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 LECTEC NON-INVASIVE PACING ELECTRODE?

LECTEC NON-INVASIVE PACING ELECTRODE is a medical device that received FDA 510(k) clearance on 1987-06-29. The listed applicant is Lectec Corp.. The 510(k) number is K872012.

When did LECTEC NON-INVASIVE PACING ELECTRODE receive FDA 510(k) clearance?

LECTEC NON-INVASIVE PACING ELECTRODE received FDA 510(k) clearance on 1987-06-29, under 510(k) number K872012.

Who is the listed applicant for LECTEC NON-INVASIVE PACING ELECTRODE?

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

What is the FDA product code for LECTEC NON-INVASIVE PACING ELECTRODE?

The FDA product code for LECTEC NON-INVASIVE PACING ELECTRODE is DRO.

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Other records listing Lectec Corp. as applicant

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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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