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510(k) Data Aggregation
K Number
K971444Device Name
3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
Manufacturer
3M MEDICAL PRODUCTS GROUP
Date Cleared
1997-06-11
(51 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
3M MEDICAL PRODUCTS GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are intended for use in ECG Monitoring Procedures. The 2234 & 2266 Radiolucent Monitoring Electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be used for short term and long term (up to 3 days) monitoring.
Device Description
The 3MTM Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are a selfadhesive, non-sterile, single use, disposable electrode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a self-adhesive tape backing which holds the conductive elements of the electrode in place on the patient's skin for short or long term (up to 3 days) for ECG monitoring. The 3MTM Red Dot™ 2234 & Radiolucent Monitoring Electrode with Clear Tape is composed of the same materials as the predicate device 3MTM Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the snap which has been modified to include a higher percentage of carbon. The 3M™ Red Dot™ 2266 Radiolucent Monitoring Electrode with Breathable Comfort Backing is composed of the same materials as the predicate device 3M™ Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the sensing snap which has been modified to include a higher percentage of carbon and the tape backing and adhesive.
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K Number
K955103Device Name
3M NO STING BARRIER FILM
Manufacturer
3M MEDICAL PRODUCTS GROUP
Date Cleared
1996-02-05
(89 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
3M MEDICAL PRODUCTS GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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