The following data is part of a premarket notification filed by Home Dialysis Plus with the FDA for Tablo Console.
| Device ID | K140866 |
| 510k Number | K140866 |
| Device Name: | TABLO CONSOLE |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | HOME DIALYSIS PLUS 257 HUMBOLDT COURT Sunnyvale, CA 94089 |
| Contact | Nancy Gallo |
| Correspondent | Nancy Gallo HOME DIALYSIS PLUS 257 HUMBOLDT COURT Sunnyvale, CA 94089 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-03 |
| Decision Date | 2014-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850001011006 | K140866 | 000 |
| 20850001011024 | K140866 | 000 |