DISPOSABLE DIAPHRAGM DOMES

Transducer, Blood-pressure, Extravascular

MEDEX, INC.

The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Disposable Diaphragm Domes.

Pre-market Notification Details

Device IDK820355
510k NumberK820355
Device Name:DISPOSABLE DIAPHRAGM DOMES
ClassificationTransducer, Blood-pressure, Extravascular
Applicant MEDEX, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDRS  
CFR Regulation Number870.2850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-08
Decision Date1982-03-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35019517090417 K820355 000
50351688504669 K820355 000
50351688505062 K820355 000
50351688504690 K820355 000
50351688517881 K820355 000
50351688504713 K820355 000
50351688510738 K820355 000

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