PRESSURE TUBING-ADULT & PEDIATRIC

Transducer, Blood-pressure, Extravascular

GOULD, INC.

The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Pressure Tubing-adult & Pediatric.

Pre-market Notification Details

Device IDK821450
510k NumberK821450
Device Name:PRESSURE TUBING-ADULT & PEDIATRIC
ClassificationTransducer, Blood-pressure, Extravascular
Applicant GOULD, 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 Received1982-05-14
Decision Date1982-05-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884450372115 K821450 000
20884450372139 K821450 000
20884450372061 K821450 000

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