CERVIX COIL LATEX SHEATH

Coil, Magnetic Resonance, Specialty

PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Cervix Coil Latex Sheath.

Pre-market Notification Details

Device IDK981406
510k NumberK981406
Device Name:CERVIX COIL LATEX SHEATH
ClassificationCoil, Magnetic Resonance, Specialty
Applicant PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights,  OH  44143
ContactElaine K Keeler
CorrespondentElaine K Keeler
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights,  OH  44143
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-20
Decision Date1998-07-16
Summary:summary

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