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FDA 510(k)

ZOLL D-900 DEFIBRILLATOR

K-Number: K913484 · 1991-12-16

ApplicantZmi Corp.
Decision Date1991-12-16
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOLL D-900 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 1991-12-16 under 510(k) number K913484. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOLL D-900 DEFIBRILLATOR?

ZOLL D-900 DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1991-12-16. The listed applicant is Zmi Corp.. The 510(k) number is K913484.

When did ZOLL D-900 DEFIBRILLATOR receive FDA 510(k) clearance?

ZOLL D-900 DEFIBRILLATOR received FDA 510(k) clearance on 1991-12-16, under 510(k) number K913484.

Who is the listed applicant for ZOLL D-900 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 D-900 DEFIBRILLATOR?

The FDA product code for ZOLL D-900 DEFIBRILLATOR is LDD.

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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 ELECTRODESK911956ZOLL PD-1400 PACER/DEFIBRILLATORK895032ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODESK885166ZMI PART NO. NTP-2100, PEDIATRIC ELECTRODESK873402ZOLL NTP-1200 PACER/DEFIBRILLATOR

View all 8 devices →

Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, 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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