CRW-1 SYSTEM

Neurological Stereotaxic Instrument

RADIONICS SOFTWARE APPLICATIONS, INC.

The following data is part of a premarket notification filed by Radionics Software Applications, Inc. with the FDA for Crw-1 System.

Pre-market Notification Details

Device IDK944463
510k NumberK944463
Device Name:CRW-1 SYSTEM
ClassificationNeurological Stereotaxic Instrument
Applicant RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington,  MA  01803 -2591
ContactLinda Jalbert
CorrespondentLinda Jalbert
RADIONICS SOFTWARE APPLICATIONS, INC. 22 TERRY AVE. Burlington,  MA  01803 -2591
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-12
Decision Date1995-10-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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