DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)

Coil, Magnetic Resonance, Specialty

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Ds Anterior, Ds Base, Ds Head-neck, Ds Head, Flex (s,m,l).

Pre-market Notification Details

Device IDK123492
510k NumberK123492
Device Name:DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)
ClassificationCoil, Magnetic Resonance, Specialty
Applicant PHILIPS MEDICAL SYSTEMS 3545 S W 47TH AVENUE Gainesville,  FL  32608 -1099
ContactLisa Simpson
CorrespondentLisa Simpson
PHILIPS MEDICAL SYSTEMS 3545 S W 47TH AVENUE Gainesville,  FL  32608 -1099
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-13
Decision Date2012-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838086098 K123492 000
00884838066946 K123492 000
00884838066939 K123492 000
00884838065567 K123492 000
00884838065550 K123492 000
00884838065543 K123492 000
00884838065536 K123492 000
00884838065529 K123492 000
00884838065512 K123492 000
00884838066984 K123492 000
00884838067370 K123492 000
00884838067394 K123492 000
00884838086081 K123492 000
00884838086074 K123492 000
00884838086067 K123492 000
00884838086050 K123492 000
00884838086043 K123492 000
00884838086036 K123492 000
00884838086029 K123492 000
00884838085916 K123492 000
00884838065505 K123492 000

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