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FDA 510(k)

AEDEFIBRILLATOR

K-Number: K002232 · 2000-12-06

ApplicantMedical Research Laboratories, Inc.
Decision Date2000-12-06
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AEDEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medical Research Laboratories, Inc.. It received FDA 510(k) clearance on 2000-12-06 under 510(k) number K002232. 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 AEDEFIBRILLATOR?

AEDEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 2000-12-06. The listed applicant is Medical Research Laboratories, Inc.. The 510(k) number is K002232.

When did AEDEFIBRILLATOR receive FDA 510(k) clearance?

AEDEFIBRILLATOR received FDA 510(k) clearance on 2000-12-06, under 510(k) number K002232.

Who is the listed applicant for AEDEFIBRILLATOR?

The FDA 510(k) record lists Medical Research Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AEDEFIBRILLATOR?

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

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Other records listing Medical Research Laboratories, Inc. 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.

K021168JUMP START, MODEL 970300K012766PORTABLE INTENSIVE CARE UNITK012030PORTABLE INTENSIVE CARE UNITK010207PORTABLE INSTENSIVE CARE UNITK000712PORTABLE INTENSIVE CARE UNIT, MODEL PICK983307MODIFICATION TO PORTABLE INTENSIVE CARE UNIT

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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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