ABN ANEROID SPHYGMOMANOMETER

Blood Pressure Cuff

PT. SUGIH INSTRUMENDO ABADI

The following data is part of a premarket notification filed by Pt. Sugih Instrumendo Abadi with the FDA for Abn Aneroid Sphygmomanometer.

Pre-market Notification Details

Device IDK012444
510k NumberK012444
Device Name:ABN ANEROID SPHYGMOMANOMETER
ClassificationBlood Pressure Cuff
Applicant PT. SUGIH INSTRUMENDO ABADI 933A MOTOR PKWY. Hauppauge,  NY  11788
ContactRichard Graver
CorrespondentPat Paladino
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2001-08-01
Decision Date2001-08-16

NIH GUDID Devices

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