FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS— 510(k) K133119
Substantially EquivalentArjohuntleigh Polska SP Z.O.O.
FDA 510(k) clearance K133119 for FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS, Substantially Equivalent on 2014-02-28. Applicant: Arjohuntleigh Polska SP Z.O.O.. Device class: 2.
Clearance details
- Applicant
- Arjohuntleigh Polska SP Z.O.O.
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cardiff, GB
Recent devices under product code JOW
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