MONITORING KIT

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 Monitoring Kit.

Pre-market Notification Details

Device IDK833171
510k NumberK833171
Device Name:MONITORING KIT
ClassificationTransducer, Blood-pressure, Extravascular
Applicant TRANSAMERICA DELAVAL, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-09-16
Decision Date1984-09-06

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