FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
K Number: K112944
·
Decision Dec 30, 2011
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
52
Applicant Total
2
Review Days
87
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Basic Information
- Device Name
- FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
- K Number
- K112944
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3110
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fresenius Medical Care South Asia Pacific Pty , Ltd.
- Date Received
- October 4, 2011
- Decision Date
- December 30, 2011
- Product Code
- INO
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| INO | Chair, Positioning, Electric | FDA class 2 | Physical Medicine |
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Other Clearances by Fresenius Medical Care South Asia Pacific Pty , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K091727 | MEDICAL TREATMENT CHAIR, T400, T500,T600 | Jul 6, 2009 | Substantially Equivalent |