MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411— 510(k) K092793
Substantially EquivalentBio-Medical Research, Ltd.
FDA 510(k) clearance K092793 for MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411, Substantially Equivalent on 2009-12-07. Applicant: Bio-Medical Research, Ltd.. Device class: 2.
Clearance details
- Applicant
- Bio-Medical Research, Ltd.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Galway, IE
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