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FDA 510(k)

RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM

K-Number: K963120 · 1997-02-28

ApplicantMarquette Electronics, Inc.
Decision Date1997-02-28
Product CodeDRO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K963120. The device is classified under product code DRO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM?

RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K963120.

When did RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM receive FDA 510(k) clearance?

RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM received FDA 510(k) clearance on 1997-02-28, under 510(k) number K963120.

Who is the listed applicant for RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM?

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

What is the FDA product code for RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM?

The FDA product code for RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM is DRO.

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Other records listing Marquette Electronics, Inc. as applicant

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K971868IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEMK971683WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNETK972199SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSISK962547CARDIOSERV PK962827ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)K964750EAGLE 4000 PATIENT MONITOR

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Related Devices (Code: DRO)

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.

K012218LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODESThe Ludlow Company LPK012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85Katecho, Inc.K000660ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413Medical Data ElectronicsK983196PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)Tz Medical, Inc.K983232PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERTTz Medical, Inc.K974034PORTABLE INTENSIVE CARE UNITMedical Research Laboratories, 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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