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FDA 510(k)

CARDIOSOFT/CARDIOSYS

K-Number: K951130 · 1996-04-04

ApplicantMarquette Electronics, Inc.
Decision Date1996-04-04
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDIOSOFT/CARDIOSYS 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 1996-04-04 under 510(k) number K951130. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOSOFT/CARDIOSYS?

CARDIOSOFT/CARDIOSYS is a medical device that received FDA 510(k) clearance on 1996-04-04. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K951130.

When did CARDIOSOFT/CARDIOSYS receive FDA 510(k) clearance?

CARDIOSOFT/CARDIOSYS received FDA 510(k) clearance on 1996-04-04, under 510(k) number K951130.

Who is the listed applicant for CARDIOSOFT/CARDIOSYS?

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 CARDIOSOFT/CARDIOSYS?

The FDA product code for CARDIOSOFT/CARDIOSYS is LOS.

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Other records listing Marquette Electronics, 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.

K971868IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEMK971683WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNETK972199SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSISK962547CARDIOSERV PK963120RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEMK962827ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)

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Related Devices (Code: LOS)

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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., 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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