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FDA 510(k)

HEART*AID 1000

K-Number: K870622 · 1987-04-10

ApplicantCardiac Resucitator Corp.
Decision Date1987-04-10
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART*AID 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Resucitator Corp.. It received FDA 510(k) clearance on 1987-04-10 under 510(k) number K870622. 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 HEART*AID 1000?

HEART*AID 1000 is a medical device that received FDA 510(k) clearance on 1987-04-10. The listed applicant is Cardiac Resucitator Corp.. The 510(k) number is K870622.

When did HEART*AID 1000 receive FDA 510(k) clearance?

HEART*AID 1000 received FDA 510(k) clearance on 1987-04-10, under 510(k) number K870622.

Who is the listed applicant for HEART*AID 1000?

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

What is the FDA product code for HEART*AID 1000?

The FDA product code for HEART*AID 1000 is MKJ. This falls under the Dental category.

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Other records listing Cardiac Resucitator 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.

K882513MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATORK871971MODIFIED PACE*AID MODEL 53K871538STAT-PAD (TM)K871569MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATORK850596PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &K850170HEART AID MODEL 97

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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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