SMARTSIGNS MINPULSE

Oximeter

HUNTLEIGH HEALTHCARE LTD.

The following data is part of a premarket notification filed by Huntleigh Healthcare Ltd. with the FDA for Smartsigns Minpulse.

Pre-market Notification Details

Device IDK081572
510k NumberK081572
Device Name:SMARTSIGNS MINPULSE
ClassificationOximeter
Applicant HUNTLEIGH HEALTHCARE LTD. 35 PORTMANMOOR RD. Cardiff, South Glamorgan,  GB Cf24 5hn
ContactRobert Mccarthy
CorrespondentRobert Mccarthy
HUNTLEIGH HEALTHCARE LTD. 35 PORTMANMOOR RD. Cardiff, South Glamorgan,  GB Cf24 5hn
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-04
Decision Date2008-10-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05051968022264 K081572 000
05051968022240 K081572 000

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