510(k) K143438
K143438 is an FDA 510(k) premarket notification submitted by Getinge (Suzhou) Co., Ltd. for the device "Flowtron ACS900". The FDA issued a decision of Substantially Equivalent on June 23, 2015. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Getinge (Suzhou) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2015
- Date Received
- December 2, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type