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FDA 510(k)

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG

K-Number: K880780 · 1988-05-12

ApplicantFirst Medical Devices Corp.
Decision Date1988-05-12
Product CodeDRL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG is the device name listed in this FDA 510(k) record. The listed applicant is First Medical Devices Corp.. It received FDA 510(k) clearance on 1988-05-12 under 510(k) number K880780. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG?

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG is a medical device that received FDA 510(k) clearance on 1988-05-12. The listed applicant is First Medical Devices Corp.. The 510(k) number is K880780.

When did HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG receive FDA 510(k) clearance?

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG received FDA 510(k) clearance on 1988-05-12, under 510(k) number K880780.

Who is the listed applicant for HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG?

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

What is the FDA product code for HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG?

The FDA product code for HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG is DRL.

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 First Medical Devices 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.

K903657MODEL 610 MODIFIEDK895185FIRST MEDIC MODEL 610PK883584FIRST MEDIC MODE 610K871136HEARTSTART 2000, MANUAL DEFIBRILLATORK871135HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULEK860676HEARTSTART 2000

View all 7 devices →

Related Devices (Code: DRL)

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.

K190437Delta 3300Netech CorporationK182905UniPulseSeaward GroupK110192DEFIBRILLATOR ANALYZER - DA-2006PBc Group International, Inc.K083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADSFluke BiomedicalK072114IMPULSE 6000D/7000DPFluke BiomedicalK062099PHASE 3, MODEL DT-1Datrend Systems, Inc.

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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