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Found 4 results
510(k) Data Aggregation
K Number
K042315Device Name
CEREBRAL STATE MONITOR - CSM
Manufacturer
DANMETER A/S
Date Cleared
2005-01-21
(148 days)
Product Code
OLW, OMC, ORT
Regulation Number
882.1400Why did this record match?
Applicant Name (Manufacturer) :
DANMETER A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CSM monitor is intended for use in monitoring the hypnotic state of the brain by data acquisition of EEG signals of the anaesthetized or sedated patient in all areas of the hospital.
Device Description
The Cerebral State Monitor (CSM) is a non-invasive measurement tool for use by trained healthcare professionals to measure the level of consciousness (LOC) in all areas of the hospital. Based on EEG, an index (CSI) is calculated, which is used in the estimation of LOC. The CSM displays the CSI but does not perform any data interpretation (i.e., all data interpretation is performed by a physician).
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K Number
K032954Device Name
ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80
Manufacturer
DANMETER A/S
Date Cleared
2004-08-09
(322 days)
Product Code
IPF, GZJ
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
DANMETER A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ELPHA // 500, ELPHA // 1000: This Danmeter device is designed for the symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
ELPHA // 2000: This Danmeter device is designed for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.
ELPHA II 3000: This Danmeter device is designed for:
- Symptomatic relief and management of chronic (long-term), intractable pain and as an adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
- Relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.
Device Description
Not Found
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K Number
K032955Device Name
AUTOMOVE, MODEL AM800
Manufacturer
DANMETER A/S
Date Cleared
2003-12-15
(84 days)
Product Code
IPF
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
DANMETER A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stroke Rehab by Muscle Reeducation
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Device Description
Not Found
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K Number
K032988Device Name
ELPHA 4 CONTI
Manufacturer
DANMETER A/S
Date Cleared
2003-12-03
(70 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
DANMETER A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrical stimulation of the pelvic floor muscles with the use of vaginal probe. The effect is strengthening the pelvic floor muscles and an activation of the central nervous system.
Electrical stimulation of the pelvic floor muscles can reduce urinary incontinence among stress and urge incontinent adult females.
Device Description
Not Found
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