The following data is part of a premarket notification filed by Getinge (suzhou) Co., Ltd with the FDA for Flowtron Acs900.
Device ID | K143438 |
510k Number | K143438 |
Device Name: | Flowtron ACS900 |
Classification | Sleeve, Limb, Compressible |
Applicant | Getinge (Suzhou) Co., Ltd No. 158 Fangzhou Road Suzhou, TW 215024 |
Contact | Lenda Hou |
Correspondent | David Moynham ArjoHuntleigh AB 35 Portmanmoor Road Cardiff, GB Cf24 5hn |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-02 |
Decision Date | 2015-06-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05055982700429 | K143438 | 000 |
05055982700412 | K143438 | 000 |
05055982700405 | K143438 | 000 |
05055982700399 | K143438 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FLOWTRON ACS900 79326321 not registered Live/Pending |
Arjo IP Holding AB 2021-06-30 |