The following data is part of a premarket notification filed by Fresenius Medical Care Rental Therapies Group, Llc with the FDA for Aquaa.
| Device ID | K213507 |
| 510k Number | K213507 |
| Device Name: | AquaA |
| Classification | Subsystem, Water Purification |
| Applicant | Fresenius Medical Care Rental Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Contact | Denise Oppermann |
| Correspondent | Denise Oppermann Fresenius Medical Care Rental Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-01 |
| Decision Date | 2022-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251285200517 | K213507 | 000 |
| 04251285200395 | K213507 | 000 |
| 04251285200388 | K213507 | 000 |
| 04251285200371 | K213507 | 000 |
| 04251285200364 | K213507 | 000 |
| 04251285200357 | K213507 | 000 |
| 04251285200340 | K213507 | 000 |
| 04251285200333 | K213507 | 000 |
| 04251285200326 | K213507 | 000 |
| 04251285200401 | K213507 | 000 |
| 04251285200418 | K213507 | 000 |
| 04251285200425 | K213507 | 000 |
| 04251285200500 | K213507 | 000 |
| 04251285200494 | K213507 | 000 |
| 04251285200487 | K213507 | 000 |
| 04251285200470 | K213507 | 000 |
| 04251285200463 | K213507 | 000 |
| 04251285200456 | K213507 | 000 |
| 04251285200449 | K213507 | 000 |
| 04251285200432 | K213507 | 000 |
| 04251285200319 | K213507 | 000 |