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FDA 510(k)

ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES

K-Number: K885166 · 1989-05-01

ApplicantZmi Corp.
Decision Date1989-05-01
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Zmi Corp.. It received FDA 510(k) clearance on 1989-05-01 under 510(k) number K885166. 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 ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES?

ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES is a medical device that received FDA 510(k) clearance on 1989-05-01. The listed applicant is Zmi Corp.. The 510(k) number is K885166.

When did ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES receive FDA 510(k) clearance?

ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES received FDA 510(k) clearance on 1989-05-01, under 510(k) number K885166.

Who is the listed applicant for ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES?

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

What is the FDA product code for ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES?

The FDA product code for ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODES is DRO.

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Other records listing Zmi 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.

K915100BRINDLEY & SMITH ET-1000K915159PEDIATRIC MULTI-FUNCTION ELECTRODESK913484ZOLL D-900 DEFIBRILLATORK911956ZOLL PD-1400 PACER/DEFIBRILLATORK895032ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODESK873402ZOLL NTP-1200 PACER/DEFIBRILLATOR

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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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