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FDA 510(k)

HEARTSTART 911

K-Number: K954609 · 1996-01-04

ApplicantLaerdal Medical Corp.
Decision Date1996-01-04
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSTART 911 is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Medical Corp.. It received FDA 510(k) clearance on 1996-01-04 under 510(k) number K954609. 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 911?

HEARTSTART 911 is a medical device that received FDA 510(k) clearance on 1996-01-04. The listed applicant is Laerdal Medical Corp.. The 510(k) number is K954609.

When did HEARTSTART 911 receive FDA 510(k) clearance?

HEARTSTART 911 received FDA 510(k) clearance on 1996-01-04, under 510(k) number K954609.

Who is the listed applicant for HEARTSTART 911?

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

What is the FDA product code for HEARTSTART 911?

The FDA product code for HEARTSTART 911 is MKJ. This falls under the Dental category.

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Other records listing Laerdal Medical 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.

K001742RESUSCI INFLATE-A-SHIELD CPR BARRIERK962361TRACHLIGHT STYLET AND TRACHEAL LIGHTWANDK954771TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)K950698LSU 2000 PORTABLE SUCTION UNITK933048LAERDAL(TM) POCKET MASK, MODIFICATIONK896919HEARTSTART 3000

View all 11 devices →

Related Devices (Code: MKJ)

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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART 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.

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