Disposable Intraoperative Probe (DIOP8)

Transducer, Ultrasonic, Diagnostic

Huntleigh Healthcare Limited

The following data is part of a premarket notification filed by Huntleigh Healthcare Limited with the FDA for Disposable Intraoperative Probe (diop8).

Pre-market Notification Details

Device IDK201425
510k NumberK201425
Device Name:Disposable Intraoperative Probe (DIOP8)
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant Huntleigh Healthcare Limited 35 Portmanmoor Road Cardiff,  GB Cf24 5hn
ContactSteve Monks
CorrespondentSteve Monks
Huntleigh Healthcare Limited 35 Portmanmoor Road Cardiff,  GB Cf24 5hn
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-29
Decision Date2021-02-19

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