The following data is part of a premarket notification filed by Fresenius Medical Care South Asia Pacific Pty Ltd. with the FDA for Medical Treatment Chair, T400, T500,t600.
| Device ID | K091727 |
| 510k Number | K091727 |
| Device Name: | MEDICAL TREATMENT CHAIR, T400, T500,T600 |
| Classification | Chair, Positioning, Electric |
| Applicant | FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. LEVEL 17, 61 LAVENDER STREET Milsons Point, Nsw, AU 2061 |
| Contact | Ram Kamath |
| Correspondent | Ram Kamath FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD. LEVEL 17, 61 LAVENDER STREET Milsons Point, Nsw, 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 | 2009-06-11 |
| Decision Date | 2009-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04052882002883 | K091727 | 000 |