FDA 510(k)

HEARTSTART 2000

K-Number: K860676 · 1986-04-30

Decision Date1986-04-30

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HEARTSTART 2000 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 1986-04-30 under 510(k) number K860676. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTSTART 2000?

HEARTSTART 2000 is a medical device that received FDA 510(k) clearance on 1986-04-30. The listed applicant is First Medical Devices Corp.. The 510(k) number is K860676.

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

HEARTSTART 2000 received FDA 510(k) clearance on 1986-04-30, under 510(k) number K860676.

Who is the listed applicant for HEARTSTART 2000?

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?

The FDA product code for HEARTSTART 2000 is MKJ. This falls under the Dental category.

Related Clinical Trials

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.

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Other records listing First Medical Devices Corp. as applicant

K903657MODEL 610 MODIFIED K895185FIRST MEDIC MODEL 610P K883584FIRST MEDIC MODE 610 K880780HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG K871136HEARTSTART 2000, MANUAL DEFIBRILLATOR K871135HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

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Related Devices (Code: MKJ)

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical Systems K131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

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.