NDI PASSIVE SPHERES

Neurological Stereotaxic Instrument

NORTHERN DIGITAL, INC.

The following data is part of a premarket notification filed by Northern Digital, Inc. with the FDA for Ndi Passive Spheres.

Pre-market Notification Details

Device IDK033621
510k NumberK033621
Device Name:NDI PASSIVE SPHERES
ClassificationNeurological Stereotaxic Instrument
Applicant NORTHERN DIGITAL, INC. 4 INNOVATION DRIVE Dundas, Ontario,  CA L9h 7p3
ContactNancy Ruth
CorrespondentNancy Ruth
NORTHERN DIGITAL, INC. 4 INNOVATION DRIVE Dundas, Ontario,  CA L9h 7p3
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-18
Decision Date2004-01-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00805832070043 K033621 000
00805832020024 K033621 000
00805832020031 K033621 000
20805832020042 K033621 000
20805832030010 K033621 000
20805832030027 K033621 000
20805832030034 K033621 000
20805832030041 K033621 000
20805832040019 K033621 000
20805832040026 K033621 000
20805832040033 K033621 000
20805832070016 K033621 000
20805832070023 K033621 000
20805832070030 K033621 000
00805832020017 K033621 000

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