Submission Details
| 510(k) Number | K112944 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 04, 2011 |
| Decision Date | December 30, 2011 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
Dec 2011
Decision
87d
Days
Class 2
Risk
About This 510(k) Submission
K112944 is an FDA 510(k) clearance for the FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES, a Chair, Positioning, Electric (Class II — Special Controls, product code INO), submitted by Fresenius Medical Care South Asia Pacific Pty , Ltd. (Milsons Point,, AU). The FDA issued a Cleared decision on December 30, 2011, 87 days after receiving the submission on October 4, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3110.
Device Classification
| Product Code | INO — Chair, Positioning, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.3110 |
Manufacturer
Fresenius Medical Care South Asia Pacific Pty , Ltd.
Milsons Point, · AU
RAM KAMATH
2 submissions
2 cleared
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