DYNAMARK 1000

System, Measurement, Blood-pressure, Non-invasive

DYNAMEDICS, INC.

The following data is part of a premarket notification filed by Dynamedics, Inc. with the FDA for Dynamark 1000.

Pre-market Notification Details

Device IDK873979
510k NumberK873979
Device Name:DYNAMARK 1000
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant DYNAMEDICS, INC. 200 PROSPECT ST. Waltham,  MA  02154
ContactRobert J Witkop
CorrespondentRobert J Witkop
DYNAMEDICS, INC. 200 PROSPECT ST. Waltham,  MA  02154
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-30
Decision Date1987-11-27

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