DOPPLEX ABILITY

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

HUNTLEIGH HEALTHCARE

The following data is part of a premarket notification filed by Huntleigh Healthcare with the FDA for Dopplex Ability.

Pre-market Notification Details

Device IDK121108
510k NumberK121108
Device Name:DOPPLEX ABILITY
ClassificationPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant HUNTLEIGH HEALTHCARE 35 PORTMANMOOR ROAD Cardiff,  GB Cf24 5hn
ContactDavid Moynham
CorrespondentDavid Moynham
HUNTLEIGH HEALTHCARE 35 PORTMANMOOR ROAD Cardiff,  GB Cf24 5hn
Product CodeJOM  
CFR Regulation Number870.2780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-12
Decision Date2013-01-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05051968030511 K121108 000
05051968030030 K121108 000
05051968030337 K121108 000
05051968030344 K121108 000
05051968030351 K121108 000
05051968030368 K121108 000
05051968030375 K121108 000
05051968030412 K121108 000
05051968030429 K121108 000
05051968030436 K121108 000
05051968030474 K121108 000
05051968030481 K121108 000
05051968030498 K121108 000
05051968030504 K121108 000
05051968035370 K121108 000

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