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510(k) Data Aggregation
K Number
K012011Device Name
MODIFICATION TO A620 EEG
Manufacturer
Date Cleared
2001-10-10
(104 days)
Product Code
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
STOELTING CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EEG/Neurofeedback is indicated where general relaxation training is desired.
The Model A620-3 EEG biofeedback instrument is used by professionals for general relaxation training of patients.
Device Description
Autogenics Model A620-3 EEG Biofeedback Instrument
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K Number
K965006Device Name
AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER)
Manufacturer
Date Cleared
1997-02-05
(51 days)
Product Code
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
STOELTING CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K952797Device Name
AT53 DUAL CHANNEL EMG
Manufacturer
Date Cleared
1996-04-17
(303 days)
Product Code
Regulation Number
882.5050Why did this record match?
Applicant Name (Manufacturer) :
STOELTING CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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