Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

12SSL ECG ANALYSIS PROG.(SCALER LEAD)

K-Number: K802369 · 1980-11-12

ApplicantMarquette Electronics, Inc.
Decision Date1980-11-12
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

12SSL ECG ANALYSIS PROG.(SCALER LEAD) 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 1980-11-12 under 510(k) number K802369. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 12SSL ECG ANALYSIS PROG.(SCALER LEAD)?

12SSL ECG ANALYSIS PROG.(SCALER LEAD) is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K802369.

When did 12SSL ECG ANALYSIS PROG.(SCALER LEAD) receive FDA 510(k) clearance?

12SSL ECG ANALYSIS PROG.(SCALER LEAD) received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802369.

Who is the listed applicant for 12SSL ECG ANALYSIS PROG.(SCALER LEAD)?

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 12SSL ECG ANALYSIS PROG.(SCALER LEAD)?

The FDA product code for 12SSL ECG ANALYSIS PROG.(SCALER LEAD) is LOS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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)

View all 82 devices →

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.

↑