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FDA 510(k)

ZOLL PD-1400 PACER/DEFIBRILLATOR

K-Number: K911956 · 1991-07-31

ApplicantZmi Corp.
Decision Date1991-07-31
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL PD-1400 PACER/DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Zmi Corp.. It received FDA 510(k) clearance on 1991-07-31 under 510(k) number K911956. 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 ZOLL PD-1400 PACER/DEFIBRILLATOR?

ZOLL PD-1400 PACER/DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1991-07-31. The listed applicant is Zmi Corp.. The 510(k) number is K911956.

When did ZOLL PD-1400 PACER/DEFIBRILLATOR receive FDA 510(k) clearance?

ZOLL PD-1400 PACER/DEFIBRILLATOR received FDA 510(k) clearance on 1991-07-31, under 510(k) number K911956.

Who is the listed applicant for ZOLL PD-1400 PACER/DEFIBRILLATOR?

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 ZOLL PD-1400 PACER/DEFIBRILLATOR?

The FDA product code for ZOLL PD-1400 PACER/DEFIBRILLATOR is DRO.

Related Clinical Trials

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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 DEFIBRILLATORK895032ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODESK885166ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODESK873402ZOLL NTP-1200 PACER/DEFIBRILLATOR

View all 8 devices →

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.

K012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK000660ESCORT 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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