The following data is part of a premarket notification filed by Fresenius Medical Care South Asia Pacific Pty Ltd. with the FDA for Fresenius Medical Treatment Chair T688 Series.
| Device ID | K112944 |
| 510k Number | K112944 |
| Device Name: | FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES |
| Classification | Chair, Positioning, Electric |
| Applicant | FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. LEVEL 17, 61 LAVENDER STREET Milsons Point,, AU 2061 |
| Contact | Ram Kamath |
| Correspondent | Ram Kamath FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. LEVEL 17, 61 LAVENDER STREET Milsons Point,, AU 2061 |
| Product Code | INO |
| CFR Regulation Number | 890.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-04 |
| Decision Date | 2011-12-30 |
| Summary: | summary |