AltaTrack Equipment, AltaTrack Guidewire, AltaTrack Catheter

Computer, Diagnostic, Programmable

Philips Medical System Nederland B.V.

The following data is part of a premarket notification filed by Philips Medical System Nederland B.v. with the FDA for Altatrack Equipment, Altatrack Guidewire, Altatrack Catheter.

Pre-market Notification Details

Device IDK201081
510k NumberK201081
Device Name:AltaTrack Equipment, AltaTrack Guidewire, AltaTrack Catheter
ClassificationComputer, Diagnostic, Programmable
Applicant Philips Medical System Nederland B.V. Veenpluis 4-6 Best,  NL 5684 Pc
ContactGert De Vries
CorrespondentGert De Vries
Philips Medical System Nederland B.V. Veenpluis 4-6 Best,  NL 5684 Pc
Product CodeDQK  
Subsequent Product CodeDQO
Subsequent Product CodeDQX
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-22
Decision Date2020-12-17

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