IOP8 INTRA OPERATIVE PROBE

Transducer, Ultrasonic, Diagnostic

HUNTLEIGH HEALTHCARE, INC.

The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Iop8 Intra Operative Probe.

Pre-market Notification Details

Device IDK032315
510k NumberK032315
Device Name:IOP8 INTRA OPERATIVE PROBE
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant HUNTLEIGH HEALTHCARE, INC. 35 PORTMANMOOR ROAD Cardiff,  GB Cf24 5hn
ContactB.j. Colleypriest
CorrespondentB.j. Colleypriest
HUNTLEIGH HEALTHCARE, INC. 35 PORTMANMOOR ROAD Cardiff,  GB Cf24 5hn
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-28
Decision Date2004-11-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05051968022981 K032315 000
05051968020536 K032315 000
05051968020482 K032315 000
05051968020161 K032315 000
05051968020154 K032315 000
05051968041388 K032315 000
05051968041371 K032315 000

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