FDA 510(k)

HEARTSTART 1000

K-Number: K883341 · 1988-09-12

Decision Date1988-09-12

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HEARTSTART 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Mfg. Corp.. It received FDA 510(k) clearance on 1988-09-12 under 510(k) number K883341. 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 1000?

HEARTSTART 1000 is a medical device that received FDA 510(k) clearance on 1988-09-12. The listed applicant is Laerdal Mfg. Corp.. The 510(k) number is K883341.

When did HEARTSTART 1000 receive FDA 510(k) clearance?

HEARTSTART 1000 received FDA 510(k) clearance on 1988-09-12, under 510(k) number K883341.

Who is the listed applicant for HEARTSTART 1000?

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

What is the FDA product code for HEARTSTART 1000?

The FDA product code for HEARTSTART 1000 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 Laerdal Mfg. Corp. as applicant

K902429MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE K900169MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE K885186HEARTSTART 2000 DEFIBRILLATION ELECTRODE K883344HEARTSTART 1000S

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.