DOME, DISPOSABLE, STERILE

Transducer, Blood-pressure, Extravascular

TRANSAMERICA DELAVAL, INC.

The following data is part of a premarket notification filed by Transamerica Delaval, Inc. with the FDA for Dome, Disposable, Sterile.

Pre-market Notification Details

Device IDK851989
510k NumberK851989
Device Name:DOME, DISPOSABLE, STERILE
ClassificationTransducer, Blood-pressure, Extravascular
Applicant TRANSAMERICA DELAVAL, INC. 325 HALSTEAD ST. P.O. BIN 7087 Pasadena,  CA  91109
ContactRichard G Ekstrom
CorrespondentRichard G Ekstrom
TRANSAMERICA DELAVAL, INC. 325 HALSTEAD ST. P.O. BIN 7087 Pasadena,  CA  91109
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-07
Decision Date1985-08-19

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