Flowtron ACS900
FDA 510(k) clearance K143438 · decided 2015-06-23
Clearance details
- K-number
- K143438
- Device name
- Flowtron ACS900
- Applicant
- Getinge (Suzhou) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-02
- Decision date
- 2015-06-23
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Suzhou, TW
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the recall (Z-2714-2017) | Arjo, Inc. dba ArjoHuntleigh | 2017-06-26 |