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FDA 510(k)

MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR

K-Number: K882513 · 1988-07-12

ApplicantCardiac Resucitator Corp.
Decision Date1988-07-12
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR 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 1988-07-12 under 510(k) number K882513. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR?

MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1988-07-12. The listed applicant is Cardiac Resucitator Corp.. The 510(k) number is K882513.

When did MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR receive FDA 510(k) clearance?

MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR received FDA 510(k) clearance on 1988-07-12, under 510(k) number K882513.

Who is the listed applicant for MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR?

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 MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR?

The FDA product code for MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATOR is DSI.

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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.

K871971MODIFIED PACE*AID MODEL 53K871538STAT-PAD (TM)K871569MODIFIED HEART*AID 97 AUTO. EXTERNAL DEFIBRILLATORK870622HEART*AID 1000K850596PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &K850170HEART AID MODEL 97

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Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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