ARIETTA 750

System, Imaging, Pulsed Doppler, Ultrasonic

Hitachi Healthcare Americas

The following data is part of a premarket notification filed by Hitachi Healthcare Americas with the FDA for Arietta 750.

Pre-market Notification Details

Device IDK191233
510k NumberK191233
Device Name:ARIETTA 750
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Applicant Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg,  OH  44087
ContactAaron Pierce
CorrespondentAaron Pierce
Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg,  OH  44087
Product CodeIYN  
Subsequent Product CodeITX
Subsequent Product CodeIYO
CFR Regulation Number892.1550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-08
Decision Date2019-08-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04562122959841 K191233 000
04573596214008 K191233 000
04573596212318 K191233 000

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