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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echoencephalograph
510(k) Number K853432
Device Name 5.0 IOP & 7.5 IOP PROBES
Applicant
Diasonics, Inc.
1565 Barber Ln.
Milipitas,  CA  95035
Applicant Contact FLOR O FERNANDEZ
Correspondent
Diasonics, Inc.
1565 Barber Ln.
Milipitas,  CA  95035
Correspondent Contact FLOR O FERNANDEZ
Regulation Number882.1240
Classification Product Code
GXW  
Date Received08/15/1985
Decision Date 02/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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