OMNIMED SUPERIOR TRANSDUCER PROTECTOR

Protector, Transducer, Dialysis

OMNI INTL., INC.

The following data is part of a premarket notification filed by Omni Intl., Inc. with the FDA for Omnimed Superior Transducer Protector.

Pre-market Notification Details

Device IDK851734
510k NumberK851734
Device Name:OMNIMED SUPERIOR TRANSDUCER PROTECTOR
ClassificationProtector, Transducer, Dialysis
Applicant OMNI INTL., INC. 870 RESEARCH DR. UNIT 5 Palm Springs,  CA  92263
ContactRaman Kadevari
CorrespondentRaman Kadevari
OMNI INTL., INC. 870 RESEARCH DR. UNIT 5 Palm Springs,  CA  92263
Product CodeFIB  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-25
Decision Date1985-05-23

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