DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES

System, Measurement, Blood-pressure, Non-invasive

OHMEDA MEDICAL

The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Dtx And Dtx Plus Disposable Pressure Transducers And Accessories.

Pre-market Notification Details

Device IDK935782
510k NumberK935782
Device Name:DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant OHMEDA MEDICAL 1900 WILLIAMS DR. Oxnard,  CA  93030 -2691
ContactCheryl L Shea
CorrespondentCheryl L Shea
OHMEDA MEDICAL 1900 WILLIAMS DR. Oxnard,  CA  93030 -2691
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-06
Decision Date1994-08-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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