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FDA 510(k)

HEARTSTART 2000, MANUAL DEFIBRILLATOR

K-Number: K871136 · 1987-05-12

ApplicantFirst Medical Devices Corp.
Decision Date1987-05-12
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSTART 2000, MANUAL DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is First Medical Devices Corp.. It received FDA 510(k) clearance on 1987-05-12 under 510(k) number K871136. 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 HEARTSTART 2000, MANUAL DEFIBRILLATOR?

HEARTSTART 2000, MANUAL DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1987-05-12. The listed applicant is First Medical Devices Corp.. The 510(k) number is K871136.

When did HEARTSTART 2000, MANUAL DEFIBRILLATOR receive FDA 510(k) clearance?

HEARTSTART 2000, MANUAL DEFIBRILLATOR received FDA 510(k) clearance on 1987-05-12, under 510(k) number K871136.

Who is the listed applicant for HEARTSTART 2000, MANUAL DEFIBRILLATOR?

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

What is the FDA product code for HEARTSTART 2000, MANUAL DEFIBRILLATOR?

The FDA product code for HEARTSTART 2000, MANUAL DEFIBRILLATOR is LDD.

Related Clinical Trials

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Other records listing First Medical Devices 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.

K903657MODEL 610 MODIFIEDK895185FIRST MEDIC MODEL 610PK883584FIRST MEDIC MODE 610K880780HEARTSTART 2000 DEFIBRILLATOR TESTER, ECGK871135HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULEK860676HEARTSTART 2000

View all 7 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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