Flowtron ACS900

Sleeve, Limb, Compressible

Getinge (Suzhou) Co., Ltd

The following data is part of a premarket notification filed by Getinge (suzhou) Co., Ltd with the FDA for Flowtron Acs900.

Pre-market Notification Details

Device IDK143438
510k NumberK143438
Device Name:Flowtron ACS900
ClassificationSleeve, Limb, Compressible
Applicant Getinge (Suzhou) Co., Ltd No. 158 Fangzhou Road Suzhou,  TW 215024
ContactLenda Hou
CorrespondentDavid Moynham
ArjoHuntleigh AB 35 Portmanmoor Road Cardiff,  GB Cf24 5hn
Product CodeJOW  
CFR Regulation Number870.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-02
Decision Date2015-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05055982700429 K143438 000
05055982700412 K143438 000
05055982700405 K143438 000
05055982700399 K143438 000

Trademark Results [Flowtron ACS900]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLOWTRON ACS900
FLOWTRON ACS900
79326321 not registered Live/Pending
Arjo IP Holding AB
2021-06-30

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